NeoplasmsPhase 1Meteor 1NCT02783300

An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

A Phase 1 study testing GSK3326595 and Pembrolizumab in people with Neoplasms, run by GlaxoSmithKline at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: GSK3326595 and Pembrolizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 297 participants
Where: 15 sitesin 4 countries
Study dates: 30 Aug 2016to 30 Aug 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
Presence of evaluable disease
Adequate organ function (as defined in the protocol)
Reproductive criteria (as defined in the protocol).

Who cannot join

Malignancy attributed to prior solid organ transplant
Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)
History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
Select cardiac abnormalities (as defined in the protocol)
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
History of optic nerve neuropathy or neuritis.

Trial locations and contacts

15 sites in 4 countries.

Country

City, postcode or hospital

15 sites in 4 countries

United States6 sites

GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
San Antonio, Texas, 78229

Other trials in United States

Canada3 sites

GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Toronto, Ontario, M5G 1Z5

Other trials in Canada

France3 sites

GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Lyon, 69373
GSK Investigational Site
Villejuif, 94805

Other trials in France

Netherlands3 sites

GSK Investigational Site
Amsterdam, 1066 CX
GSK Investigational Site
Leiden, 2333 ZA
GSK Investigational Site
Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma

Conditions: Neoplasms
Being tested: GSK3326595, Pembrolizumab
Keywords: GSK3326595, Solid tumor, Non-Hodgkin's lymphoma (NHL), Urinary tract cancer, Dose escalation, Adenoid cystic carcinoma (ACC), Non small-cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (HNSCC), Melanoma
Medical subject headings: Neoplasms, Lymphoma, Non-Hodgkin, Urologic Neoplasms, Carcinoma, Adenoid Cystic, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK3326595Drug
GSK3326595 will be administered with and without food, in tablet and capsule formulation.
PembrolizumabDrug
Pembrolizumab will be administered.

Study groups in NCT02783300
Study group	Role	What they receive
Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to Tablet	Experimental	Participants will receive escalating doses of GSK3326595 until the maximum tolerated dose level is reached. The recommended phase 2 dose (RP2D) will be determined. Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of GSK3326595, and will be dosed with tablet and capsule to compare two formulations of GSK3326595 (capsule versus tablet). Receives: Drug: GSK3326595
Part 2: Disease-Specific Expansion cohort	Experimental	Participants with triple-negative breast cancer (TNBC), metastatic transitional cell carcinoma of the urinary system (mTCC), Grade IV anaplastic astrocytoma (glioblastoma multiforme [GBM]), non-Hodgkin's lymphoma (NHL), adenoid cystic carcinoma (ACC), hormone receptor-positive adenocarcinoma of the breast (ER+BC), human papillomavirus (HPV)-positive solid tumors of any histology, and p53-wild type non-small cell lung cancer (NSCLC) will be administered GSK3326595 at the recommended phase 2 dose (RP2D) as determined in Part 1. Receives: Drug: GSK3326595
Part 3: GSK3326595 in combination with pembrolizumab	Experimental	Participants with selected solid tumors will be administered GSK3326595 in combination with pembrolizumab as part of this dose determination study. Receives: Drug: GSK3326595; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Measured: Up to 30 months
Part 1: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Measured: Up to 30 months
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for >=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) >3x upper limit of normal (ULN)+bilirubin, >=2xULN or ALT between 3-5 X ULN with bilirubin < 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT.
Measured: Up to 21 days
Part 1: Number of Participants With Dose Modifications of GSK3326595
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Measured: Up to 30 months
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 30 months
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 30 months
Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 30 months
Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented.
Measured: Baseline (Day 1) and up to 30 months
Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Measured: Baseline (Day 1) and up to week 132
Part 1: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Measured: Baseline (Day 1) and up to week 132
Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low (<60 beats per minute (bpm)), Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 degree Celsius (°C)), Normal (>35 °C and <38 °C), High (>=38 °C); Systolic Blood Pressure:- Low (<90 millimeter of mercury (mmHg)), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 30 months
Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Measured: Up to 10 months
Part 3: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Measured: Up to 10 months
Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 and pembrolizumab have been presented.
Measured: Up to 10 months
Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Measured: Baseline (Day 1) and up to 10 months
Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Measured: Baseline (Day 1) and up to 10 months
Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Measured: Baseline (Day 1) and up to 10 months
Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive values have been presented.
Measured: Baseline (Day 1) and up to 10 months
Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Measured: Baseline (Day 1) and up to Week 42
Part 3: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Measured: Baseline (Day 1) and up to Week 42
Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low [<60 bpm], Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 C), Normal (>35 C and <38 C), High (>=38 C); Systolic Blood Pressure:- Low (<90 mmHg), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 10 months

Secondary outcomes (45)

Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Measured: Up to 42 months
Part 2: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Measured: Up to 42 months
Part 2: Number of Participants With Dose Modifications of GSK3326595
The number of participants who had any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Measured: Up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high values' have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Measured: Baseline (Day 1) and up to 42 months
Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Measured: Baseline (Day 1) and up to week 184
Part 2: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Measured: Baseline (Day 1) and up to week 184
Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low (<60 beats per minute (bpm)), Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 degree Celsius (C)), Normal (>35 C and <38 C), High (>=38 C); Systolic Blood Pressure:- Low (<90 millimeter of mercury (mmHg)), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to 42 months
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours (h) post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Part 3: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Terminal Phase Half-life (t1/2) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: Terminal Phase Half-life (t1/2) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Oral Clearance (CL/F) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 3: Oral Clearance (CL/F) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Accumulation Ratio (AR) of GSK3326595
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Part 3: Accumulation Ratio (AR) of GSK3326595
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Time Invariance (TI) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. Time invariance was calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3326595.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Part 3: Time Invariance (TI) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Overall Response Rate (ORR) Based on RECIST 1.1
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST version 1.1. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.
Measured: Up to 30 months
Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts)
Overall response rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm).
Measured: Up to 42 months
Part 2: Six-month Progression Free Survival (PFS) Rate (GBM Cohort)
Six-month progression free survival (PFS) rate was defined as the percentage of participants free from radiographic progression per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, for six months after starting GSK3326595. The RANO criteria were used to ascertain response (Wen, 2010).
Measured: At month 6
Part 2: Duration of Response (DOR) (ACC Tablet Cohort)
Duration of response (DOR) was defined as time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause, as determined by Investigator assessment.
Measured: Up to 42 months
Part 3: ORR Based on Immune-based RECIST (iRECIST) Criteria
ORR was defined as the percentage of participants with irCR or irPR per irRECIST. irCR is defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: Up to 10 months
Part 2: ORR (GBM Cohort) Based on Response Assessment Neuro-Oncology (RANO) Working Group Criteria
ORR was defined as the percentage of participants with a CR or PR, confirmed no less than 4 weeks based on the RANO criteria. CR was defined as complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, stable or improved non-enhancing (T2/FLAIR) lesions, no new lesions, participants must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was defined as at least 50% decrease compared to Baseline in the size of all measurable enhancing lesions sustained for at least 4 weeks, no progression of non-measurable disease or any new lesions, stable of lower dose of corticosteroids than Baseline dose, and stable or improved non-enhancing (T2/FLAIR) lesions.
Measured: Up to 42 months
Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Lugano Criteria for Non-Hodgkin's lymphoma cohorts.
Measured: Up to 42 months
Part 2: Overall Survival (OS) (ACC Tablet Cohort)
Overall survival (OS) was defined as time from first dose until death from any cause in ACC participants who are systemic-treatment naïve.
Measured: Up to 42 months
Part 2: Progression-free Survival
PFS was defined as time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
Measured: Up to 42 months
RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Measured: Up to maximum 42 months
RP2D Phase: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Measured: Up to maximum 42 months
RP2D Phase: Number of Participants With Dose Modifications of GSK3326595
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Measured: Up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Measured: Baseline (Day 1) and up to maximum 42 months
RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Measured: Baseline (Day 1) and up to Week 184
RP2D Phase: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Measured: Baseline (Day 1) and up to Week 184
RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs
Vital signs were measured. The abnormal vital sign ranges are: Heart Rate:- Low [<60 beats per minute (bpm)], Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 C), Normal (>35 C and <38 C), High (>=38 C); Systolic Blood Pressure:- Low (<90 mmHg), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the worst-case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Baseline (Day 1) and up to maximum 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 201630 Aug 2023

First posted26 May 2016 (estimated)
Study start30 Aug 2016
Primary completion30 Aug 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This will be a three-part study where Part 1 is dose escalation, including assessment of Food Effect and Relative Bioavailability, Part 2 is disease specific expansion cohorts to better characterize the clinical activity and safety profile of GSK3326595 and Part 3 is dose determination of GSK3326595 in combination with pembrolizumab.
Masking: None (open label)
Enrolment: 297 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783300
Sponsor's protocol ID: 204653
Other IDs: 2016-000278-39, 2016
Acronym: Meteor 1
Status last verified: Feb 2025
First submitted: 11 Apr 2016
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Gounder MM, Martin-Romano P, Italiano A, Siu LL, Cassier PA, Falchook GS, Lossos IS, Rasco DW, Hilton JF, McKean MA, Opdam FL, Strauss J, De Jonge M, Vermaat JSP, Crossman T, Zajac M, Tarkar A, Gonzalez Carreras F, Kremer BE, Barbash O, Segal S, Parasrampuria R, Postel-Vinay S. Phase Ib and dose-expansion study of GSK3326595, a PRMT5 inhibitor as monotherapy and in combination with pembrolizumab in patients with advanced cancers. Ann Oncol. 2025 Dec;36(12):1480-1491. doi: 10.1016/j.annonc.2025.08.3757. Epub 2025 Sep 9.
PubMed 40935292

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT02783300
Acronym / sponsor ID: Meteor 1 / 204653
Conditions: Neoplasms
Keywords: GSK3326595, Solid tumor, Non-Hodgkin's lymphoma (NHL), Urinary tract cancer, Dose escalation, Adenoid cystic carcinoma (ACC), Non small-cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (HNSCC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 297 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Aug 2016 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 26 May 2016 (estimated)
Results: Posted 10 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This will be a three-part study where Part 1 is dose escalation, including assessment of Food Effect and Relative Bioavailability, Part 2 is disease specific expansion cohorts to better characterize the clinical activity and safety profile of GSK3326595 and Part 3 is dose determination of GSK3326595 in combination with pembrolizumab.

Arm	Type	Receives
Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to Tablet	Experimental	Drug: GSK3326595Participants will receive escalating doses of GSK3326595 until the maximum tolerated dose level is reached. The recommended phase 2 dose (RP2D) will be determined. Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of GSK3326595, and will be dosed with tablet and capsule to compare two formulations of GSK3326595 (capsule versus tablet).
Part 2: Disease-Specific Expansion cohort	Experimental	Drug: GSK3326595Participants with triple-negative breast cancer (TNBC), metastatic transitional cell carcinoma of the urinary system (mTCC), Grade IV anaplastic astrocytoma (glioblastoma multiforme [GBM]), non-Hodgkin's lymphoma (NHL), adenoid cystic carcinoma (ACC), hormone receptor-positive adenocarcinoma of the breast (ER+BC), human papillomavirus (HPV)-positive solid tumors of any histology, and p53-wild type non-small cell lung cancer (NSCLC) will be administered GSK3326595 at the recommended phase 2 dose (RP2D) as determined in Part 1.
Part 3: GSK3326595 in combination with pembrolizumab	Experimental	Drug: GSK3326595, Drug: PembrolizumabParticipants with selected solid tumors will be administered GSK3326595 in combination with pembrolizumab as part of this dose determination study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
Presence of evaluable disease
Adequate organ function (as defined in the protocol)

Key exclusion criteria (8 listed)

Malignancy attributed to prior solid organ transplant
Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)
History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK3326595GSK3326595 will be administered with and without food, in tablet and capsule formulation.	Drug	Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to Tablet, Part 2: Disease-Specific Expansion cohort, Part 3: GSK3326595 in combination with pembrolizumab
PembrolizumabPembrolizumab will be administered.	Drug	Part 3: GSK3326595 in combination with pembrolizumab

Primary outcome

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 30 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Part 1: Number of Participants Withdrawn Due to AEs
Time frame: Up to 30 months
The data for number of participants withdrawn due to AEs have been presented.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days
DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for >=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) >3x upper limit of normal (ULN)+bilirubin, >=2xULN or ALT between 3-5 X ULN with bilirubin < 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT.
Part 1: Number of Participants With Dose Modifications of GSK3326595
Time frame: Up to 30 months
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Time frame: Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Time frame: Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Time frame: Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Time frame: Baseline (Day 1) and up to 30 months
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented.
Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)
Time frame: Baseline (Day 1) and up to week 132
Urine samples were collected from participants to assess urine pH levels.
Part 1: Changes From Baseline in Urine Specific Gravity
Time frame: Baseline (Day 1) and up to week 132
Urine samples were collected from participants to assess urine specific gravity.
Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
Time frame: Baseline (Day 1) and up to 30 months
The abnormal vital sign ranges are: Heart Rate:- Low (<60 beats per minute (bpm)), Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 degree Celsius (°C)), Normal (>35 °C and <38 °C), High (>=38 °C); Systolic Blood Pressure:- Low (<90 millimeter of mercury (mmHg)), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 10 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Part 3: Number of Participants Withdrawn Due to AEs
Time frame: Up to 10 months
The data for number of participants withdrawn due to AEs have been presented.
Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab
Time frame: Up to 10 months
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 and pembrolizumab have been presented.
Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Time frame: Baseline (Day 1) and up to 10 months
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Time frame: Baseline (Day 1) and up to 10 months
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Time frame: Baseline (Day 1) and up to 10 months
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Time frame: Baseline (Day 1) and up to 10 months
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive values have been presented.
Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH)
Time frame: Baseline (Day 1) and up to Week 42
Urine samples were collected from participants to assess urine pH levels.
Part 3: Changes From Baseline in Urine Specific Gravity
Time frame: Baseline (Day 1) and up to Week 42
Urine samples were collected from participants to assess urine specific gravity.
Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs
Time frame: Baseline (Day 1) and up to 10 months
The abnormal vital sign ranges are: Heart Rate:- Low [<60 bpm], Normal (>=60 bpm to <=100 bpm), High (>100 bpm); Temperature:- Low (<=35 C), Normal (>35 C and <38 C), High (>=38 C); Systolic Blood Pressure:- Low (<90 mmHg), Normal (>=90 mmHg to <120 mmHg), High (>=120 mmHg); Diastolic Blood Pressure:- Low (<60 mmHg), Normal (>=60 mmHg to <80 mmHg), High (>=80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.

45 secondary outcomes

Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 42 months
Part 2: Number of Participants Withdrawn Due to AEs
Time frame: Up to 42 months
Part 2: Number of Participants With Dose Modifications of GSK3326595
Time frame: Up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Time frame: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Time frame: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Time frame: Baseline (Day 1) and up to 42 months
Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Time frame: Baseline (Day 1) and up to 42 months
Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH)
Time frame: Baseline (Day 1) and up to week 184
Part 2: Changes From Baseline in Urine Specific Gravity
Time frame: Baseline (Day 1) and up to week 184
Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
Time frame: Baseline (Day 1) and up to 42 months
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours (h) post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Part 3: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Terminal Phase Half-life (t1/2) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Part 3: Terminal Phase Half-life (t1/2) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Oral Clearance (CL/F) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 3: Oral Clearance (CL/F) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Accumulation Ratio (AR) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Part 3: Accumulation Ratio (AR) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Time Invariance (TI) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Part 3: Time Invariance (TI) of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Part 1: Overall Response Rate (ORR) Based on RECIST 1.1
Time frame: Up to 30 months
Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts)
Time frame: Up to 42 months
Part 2: Six-month Progression Free Survival (PFS) Rate (GBM Cohort)
Time frame: At month 6
Part 2: Duration of Response (DOR) (ACC Tablet Cohort)
Time frame: Up to 42 months
Part 3: ORR Based on Immune-based RECIST (iRECIST) Criteria
Time frame: Up to 10 months
Part 2: ORR (GBM Cohort) Based on Response Assessment Neuro-Oncology (RANO) Working Group Criteria
Time frame: Up to 42 months
Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria
Time frame: Up to 42 months
Part 2: Overall Survival (OS) (ACC Tablet Cohort)
Time frame: Up to 42 months
Part 2: Progression-free Survival
Time frame: Up to 42 months
RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to maximum 42 months
RP2D Phase: Number of Participants Withdrawn Due to AEs
Time frame: Up to maximum 42 months
RP2D Phase: Number of Participants With Dose Modifications of GSK3326595
Time frame: Up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Time frame: Baseline (Day 1) and up to maximum 42 months
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Time frame: Baseline (Day 1) and up to maximum 42 months

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)	1	1
Part 1: GSK3326595 25mg QD	1	1
Part 1: GSK3326595 50mg QD	1	1
Part 1: GSK3326595 100mg QD	1	0
Part 1: GSK3326595 200mg QD	8	7
Part 1: GSK3326595 300mg QD	3	3
Part 1: GSK3326595 400mg QD	19	13
Part 1: GSK3326595 600mg QD	3	3
Part 1: GSK3326595 50mg Twice Daily (BID)	1	1
Part 1: GSK3326595 100mg BID	7	6
Part 1: GSK3326595 150mg BID	6	6
Part 1: GSK3326595 200mg BID	3	3
Part 1: GSK3326595 300mg QD (Food Effect)	15	8
Part 2: GSK3326595 400mg (TNBC)	0	0
Part 2: GSK3326595 400mg (mTCC)	0	0
Part 2: GSK3326595 400mg (GBM)	0	0
Part 2: GSK3326595 400mg (ER+BC)	0	0
Part 2: GSK3326595 400mg (HPV+)	0	0
Part 2: GSK3326595 400mg (ACC)	0	0
Part 2: GSK3326595 300mg (ACC)	0	0
Part 2: GSK3326595 400mg (NHL P53 Mutant)	0	0
Part 2: GSK3326595 300mg (NHL P53 Mutant)	0	0
Part 2: GSK3326595 400mg (NHL P53 Wild Type)	0	0
Part 2: GSK3326595 300mg (NHL P53 Wild Type)	0	0
Part 2: GSK3326595 400mg (NHL P53 Unknown)	0	0
Part 2: GSK3326595 300mg (NSCLC)	0	0
Part 3: GSK3326595 100mg + Pembrolizumab 200mg	0	0

Primary outcome: Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 30 months. Count of participants. Unit: Participants

Measure	Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) n = 1	Part 1: GSK3326595 25mg QD n = 1	Part 1: GSK3326595 50mg QD n = 1	Part 1: GSK3326595 100mg QD n = 1	Part 1: GSK3326595 200mg QD n = 8	Part 1: GSK3326595 300mg QD n = 3	Part 1: GSK3326595 400mg QD n = 19	Part 1: GSK3326595 600mg QD n = 3	Part 1: GSK3326595 50mg Twice Daily (BID) n = 1	Part 1: GSK3326595 100mg BID n = 7	Part 1: GSK3326595 150mg BID n = 6	Part 1: GSK3326595 200mg BID n = 3	Part 1: GSK3326595 300mg QD (Food Effect) n = 15
Any AEs	1	1	1	1	7	3	19	3	1	7	6	3	15
Any SAEs	0	0	0	0	4	1	10	1	0	2	3	3	6

Population analysed: All treated population included all participants who received at least one dose of GSK3326595.

Primary outcome: Part 1: Number of Participants Withdrawn Due to AEs

Time frame: Up to 30 months. Count of participants. Unit: Participants

Measure	Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) n = 1	Part 1: GSK3326595 25mg QD n = 1	Part 1: GSK3326595 50mg QD n = 1	Part 1: GSK3326595 100mg QD n = 1	Part 1: GSK3326595 200mg QD n = 8	Part 1: GSK3326595 300mg QD n = 3	Part 1: GSK3326595 400mg QD n = 19	Part 1: GSK3326595 600mg QD n = 3	Part 1: GSK3326595 50mg Twice Daily (BID) n = 1	Part 1: GSK3326595 100mg BID n = 7	Part 1: GSK3326595 150mg BID n = 6	Part 1: GSK3326595 200mg BID n = 3	Part 1: GSK3326595 300mg QD (Food Effect) n = 15
Value	0	0	0	0	2	0	2	0	0	0	0	1	1

Population analysed: All treated population

Primary outcome: Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Up to 21 days. Count of participants. Unit: Participants

Measure	Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) n = 1	Part 1: GSK3326595 25mg QD n = 1	Part 1: GSK3326595 50mg QD n = 1	Part 1: GSK3326595 100mg QD n = 1	Part 1: GSK3326595 200mg QD n = 8	Part 1: GSK3326595 300mg QD n = 3	Part 1: GSK3326595 400mg QD n = 19	Part 1: GSK3326595 600mg QD n = 3	Part 1: GSK3326595 50mg Twice Daily (BID) n = 1	Part 1: GSK3326595 100mg BID n = 7	Part 1: GSK3326595 150mg BID n = 6	Part 1: GSK3326595 200mg BID n = 3	Part 1: GSK3326595 300mg QD (Food Effect) n = 15
Value	0	0	0	0	0	1	2	0	0	0	1	1	0

Population analysed: All treated population

Primary outcome: Part 1: Number of Participants With Dose Modifications of GSK3326595

Time frame: Up to 30 months. Count of participants. Unit: Participants

Measure	Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) n = 1	Part 1: GSK3326595 25mg QD n = 1	Part 1: GSK3326595 50mg QD n = 1	Part 1: GSK3326595 100mg QD n = 1	Part 1: GSK3326595 200mg QD n = 8	Part 1: GSK3326595 300mg QD n = 3	Part 1: GSK3326595 400mg QD n = 19	Part 1: GSK3326595 600mg QD n = 3	Part 1: GSK3326595 50mg Twice Daily (BID) n = 1	Part 1: GSK3326595 100mg BID n = 7	Part 1: GSK3326595 150mg BID n = 6	Part 1: GSK3326595 200mg BID n = 3	Part 1: GSK3326595 300mg QD (Food Effect) n = 15
Dose interruptions	1	1	1	1	5	3	18	2	0	5	4	2	14
Dose reductions	0	0	0	0	0	1	16	2	0	2	2	3	4

Population analysed: All treated population

45 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 30 months for part 1, 42 months for part 2 and 10 months for part 3.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Part 1: GSK3326595 25mg QD	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Part 1: GSK3326595 50mg QD	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Part 1: GSK3326595 100mg QD	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1: GSK3326595 200mg QD	4 of 8 (50%)	7 of 8 (87.5%)	7 of 8
Part 1: GSK3326595 300mg QD	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Part 1: GSK3326595 400mg QD	10 of 19 (52.6%)	19 of 19 (100%)	13 of 19
Part 1: GSK3326595 600mg QD	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Part 1: GSK3326595 50mg Twice Daily (BID)	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Part 1: GSK3326595 100mg BID	2 of 7 (28.6%)	7 of 7 (100%)	6 of 7
Part 1: GSK3326595 150mg BID	3 of 6 (50%)	6 of 6 (100%)	6 of 6
Part 1: GSK3326595 200mg BID	3 of 3 (100%)	3 of 3 (100%)	3 of 3
Part 1: GSK3326595 300mg QD (Food Effect)	6 of 15 (40%)	15 of 15 (100%)	8 of 15
Part 2: GSK3326595 400mg (TNBC)	13 of 22 (59.1%)	22 of 22 (100%)	16 of 22
Part 2: GSK3326595 400mg (mTCC)	7 of 16 (43.8%)	16 of 16 (100%)	10 of 16
Part 2: GSK3326595 400mg (GBM)	15 of 29 (51.7%)	27 of 29 (93.1%)	22 of 29
Part 2: GSK3326595 400mg (ER+BC)	10 of 37 (27%)	37 of 37 (100%)	31 of 37
Part 2: GSK3326595 400mg (HPV+)

Limitations and caveats (from the sponsor): Data was not available for pharmacokinetic parameters in samples that were out of stability or lost in transit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40935292Gounder MM, Martin-Romano P, Italiano A, Siu LL, Cassier PA, Falchook GS, Lossos IS, Rasco DW, Hilton JF, McKean MA, Opdam FL, Strauss J, De Jonge M, Vermaat JSP, Crossman T, Zajac M, Tarkar A, Gonzalez Carreras F, Kremer BE, Barbash O, Segal S, Parasrampuria R, Postel-Vinay S. Phase Ib and dose-expansion study of GSK3326595, a PRMT5 inhibitor as monotherapy and in combination with pembrolizumab in patients with advanced cancers. Ann Oncol. 2025 Dec;36(12):1480-1491. doi: 10.1016/j.annonc.2025.08.3757. Epub 2025 Sep 9.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

15 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3326595 and Pembrolizumab in people with Neoplasms, run by GlaxoSmithKline at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 30 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.