Non Small Cell Lung CancerPhase 2NCT05617313
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Pembrolizumab and GT103 in people with Non Small Cell Lung Cancer and Metastatic NSCLC, run by Ryan Dackor at 6 sites in United States.
Trial summary
This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Metastatic NSCLC, Recurrent Non Small Cell Lung Cancer
- What is being tested?
- Pembrolizumab and GT103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Feb 2023to 26 Jun 2025
- Phase
- Phase 2
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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status 0 or 1 within 14 days prior to registration.
- Histologically and/or cytologically confirmed Stage III-IV recurrent or metastatic NSCLC (American Joint Committee on Cancer (AJCC) Staging Manual 8th ed).
- Relapsed or refractory to immunotherapy. NOTE: anti-PD-1/PD-L1; prior anti-CTLA4 therapy is permitted; a minimum of 2 doses of prior immunotherapy is required. Prior treatment with chemotherapy is permitted. Neoadjuvant or adjuvant therapy is considered a line of treatment if given within 6 months of recurrent/metastatic disease. No more than 2 prior lines of therapy is permitted (this does not include oral targeted therapy).
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- Patients with sensitizing EGFR, ALK, RET, ROS1, BRAF and MET exon 14 alterations must have received at least one prior oral targeted therapy and prior chemotherapy (at least one platinum doublet regimen, i.e., carboplatin/cisplatin plus pemetrexed/ paclitaxel/docetaxel/gemcitabine). NOTE: Oral targeted therapies do not count as lines of treatment, with the exception of KRAS G12C agents (sotorasib, adagrasib, similar do count toward lines of treatment). No more than 2 prior lines of therapy is permitted.
- Disease must be measurable by RECIST 1.1 criteria. Tumor lesions in a previously irradiated area are considered measurable IF progression has been demonstrated in such lesions after radiation.
- Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to C1D1.
- Hematological
- Absolute Neutrophil Count (ANC): ≥1500/µL
- Platelet Count: ≥100 000/µL
- Hemoglobin (Hgb): ≥ 9 g/dL; Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- Renal
- ---Serum creatinine OR Calculated creatinine clearance: ≤ 1.5 × ULN OR ≥ 30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- Hepatic
- Total Serum Bilirubin: ≤1.5 ×ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤1.5 × ULN)
- Aspartate aminotransferase (AST) AND Alanine aminotransferase (ALT): ≤ 2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening and within 72 hours of C1D1. See protocol for definition of childbearing potential.
- Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 14 days prior to day 1 of study drug (including investigational agents, chemotherapy, and antibody-based therapy).
- Radiation therapy within 14 days prior to day 1 of study drug. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- Intolerance to pembrolizumab or other PD-1/PD-L1 axis drug(s), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immune-stimulatory anti-tumor agents.
- Known auto-immune conditions requiring systemic immune suppression therapy other than prednisone ≤10 mg daily (or equivalent).
- History of (non-infectious) interstitial pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
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- Receipt of allogeneic transplant (stem cell transplantation or solid organ).
- Current use of medications specified by the protocol as prohibited for administration in combination with the study drugs. This includes patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to day 1 of study drug. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS), hepatitis C virus (allowed if received curative therapy), acute or chronic active hepatitis B infection, or other serious chronic infection requiring ongoing treatment. NOTE: no testing for Hepatitis B, Hepatitis C or HIV is required unless mandated by local health authority.
- Current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment on Day 1 of study drug. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
- Known active CNS metastases which are symptomatic. Eligible if metastases have been locally treated 14 days prior to Cycle 1 Day 1, are clinically controlled, or asymptomatic on Cycle 1 Day. Steroid dose must be equivalent of ≤10 mg prednisone daily or equivalent dose steroid. Untreated, asymptomatic brain metastases allowed if subject does not require corticosteroids or anticonvulsant therapy.
- History of myocardial infarction, NYHA class III or IV congestive heart failure, or unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to study enrollment.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Summit Health
Berkeley Heights, New Jersey, 07922
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Illinois Cancer Center
Chicago, Illinois, 60612
Karmanos Cancer Center (Wayne State University)
Detroit, Michigan, 48201
Duke Cancer Institute
Durham, North Carolina, 27710
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase II Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. A total of 50 patients will be treated with the combination at the safest dose of GT103 as determined in the safety lead-in. If 10 additional patients are enrolled to the dose level -1 then the maximum of 60 subjects may be accrued to this trial.
- Being tested
- Pembrolizumab, GT103
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
200 mg intravenously on Day 1 of cycle.
GT103Drug
10mg/kg taken intravenously on Day 1 of cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pembrolizumab will be given intravenously on Day 1 of the 21 day cycle (For all cycles).
GT103 dose will be determined by the safety lead in prior to the study. Dosing calculations should be based on actual body weight where applicable. It will be taken intravenously on Day 1 of the 21 day cycle (For all cycles). Receives: Drug: Pembrolizumab; Drug: GT103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The objective response rate is defined as the proportion of treated patients with radiographic partial or complete response per RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Measured: From C1D1 until death or up to a maximum of 23 months
Assess the Frequency and Severity of Adverse Events
The proportion of subjects who experience a DLT observed during the first cycle of treatment, SAEs regardless of grade or attribution, each type of AE regardless of grade or attribution. NCI CTCAE v5 will be used to grade AEs.
Following AEs were considered DLTs if occurred during first cycle of treatment and possibly, probably or definitely related to study treatment determined by investigator: Hematologic toxicities: Grade 4 neutropenia, thrombocytopenia, or anemia; Grade ≥ 3 neutropenia or thrombocytopenia lasting over 7 days; Grade 3 thrombocytopenia associated with clinically significant bleeding as judged by the investigator; Grade ≥ 3 febrile neutropenia Non-hematologic toxicities: Nausea, vomiting or diarrhea Grade ≥ 3 and lasting ≥ 3 days despite adequate supportive measures; Grade ≥ 3 ALT or AST elevation > 7 days; or per Hy's Law an AST or ALT ≥ 3 × ULN with concurrent increase in total bilirubin ≥ 2 × ULN without evidence of or alternative explanations.
Measured: From the time of signed informed consent until 30 days (+/- 14 days) after discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurred first.
Secondary outcomes (6)
Characterize PK Profile: T1/2 of GT103 in Combination With Pembrolizumab
The time for the concentration of GT103 to reach half of the level administered when given in combination with Pembrolizumab (T1/2) will be measured by pharmacokinetic analysis.
Measured: From C1D1 up to a maximum of 19 months
Characterize PK Profile: Tmax of GT103 in Combination With Pembrolizumab
The time it takes GT103 to reach maximum concentration when administered with Pembrolizumab will be measured by pharmacokinetic analysis.
Measured: From C1D1 up to a maximum of 19 months
Characterize PK Profile: Peak Plasma Concentration (Cmax)
The maximum concentration (Cmax) of GT103 in the serum after administration in combination with Pembrolizumab will be measured by pharmacokinetic analysis.
Measured: From C1D1 up to a maximum of 19 months
Characterize PK Profile: Area Under the Plasma Concentration vs Time Curve (AUC)
Area under the plasma concentration vs time curve (AUC) for GT103 will be measured by pharmacokinetic analysis.
Measured: From C1D1 up to a maximum of 19 months
Progression Free Survival (PFS)
Progression free survival is defined as the time between initiation of treatment and progression by RECIST 1.1 or death.
Progressive disease (PD) by RECIST 1.1 is defined as At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NOTE: the appearance of one or more new lesions is also considered progressions).
Measured: From C1D1 to PD or death or up to a maximum of 23 months
Overall Survival (OS)
Overall survival is defined as the time between initiation of treatment and death from any cause.
Measured: From C1D1 until death or up to a maximum of 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start17 Feb 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Why it stopped: Study terminated after completion of planned interim analysis of 21 patients.
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.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan Dackor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Grid Therapeutics
- Responsible party
- Sponsor-investigator, Ryan Dackor, Grid Therapeutics
- Investigators
- Jeffrey Clarke, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617313
- Sponsor's protocol ID
- PRO00109146
- Other IDs
- HCRN LUN21-497
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2022
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No