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Metastatic CancerPhase 1NCT02903914

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

A Phase 1 study testing INCB001158 and Pembrolizumab in people with Metastatic Cancer and Solid Tumors, run by Incyte Corporation at 20 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCB001158 and Pembrolizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
20 sitesin 4 countries
Study dates
14 Sep 2016to 15 Aug 2022
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

  • Must be age 18 or older
  • Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
  • Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life Expectancy of at least 3 months
  • Adequate hepatic, renal (moderately impaired renal function in cohort 1c only), cardiac, and hematologic function
Show all 10Show fewer
  • Measurable disease by RECISTv1.1 criteria
  • Resolution of treatment-related toxicities
  • Willingness to avoid pregnancy or fathering children
  • Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3a - 3d

Who cannot join

  • Currently pregnant or lactating
  • Unable to receive oral medications
  • Unable to receive oral or IV hydration
  • Intolerance to prior anti-PD-1/PD-L1 therapy
  • Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3e - 3h
  • Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
Show all 23Show fewer
  • Any other current or previous malignancy within 3 years except protocol allowed malignancies
  • Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
  • Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: some cohort exceptions allow anti-PD-1 therapy)
  • Active known or suspected exclusionary autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks
  • Concomitant therapy with valproic acid/valproate-containing therapies
  • Concomitant therapy with allopurinol and other xanthine oxidase inhibitors
  • History of known risks factors for bowel perforation
  • Symptomatic ascites or pleural effusion
  • Major surgery within 28 days before Cycle 1 Day 1
  • Active infection requiring within 2 weeks prior to first dose of study drug
  • Patients who have HIV, Hepatitis B or C
  • Conditions that could interfere with treatment or protocol-related procedures
  • Active, non-stable brain metastases or CNS disease
  • Known deficiencies or suspected defect in the urea cycle
  • Received live-virus vaccination within 30 days (seasonal flu vaccine allowed if non-live virus)
  • NSCLC with EGFR or ALK mutation

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

United States13 sites

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • BIDMC

    Boston, Massachusetts, 02215

  • DFCI

    Boston, Massachusetts, 02215

  • Henry Ford

    Detroit, Michigan, 48202

  • MD Anderson

    Houston, Texas, 77230-1402

  • MD Anderson

    Houston, Texas, 77230

  • University of South Alabama

    Mobile, Alabama, 36604

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Vanderbilt

    Nashville, Tennessee, 37232

  • START

    San Antonio, Texas, 78229

  • Honor Health/Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • University of Arizona

    Tucson, Arizona, 85719

  • Georgetown

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Institut Catala d'Oncologia

    Barcelona, 8908

  • START Madrid-HM CIOCC

    Madrid, 28050

Other trials in Spain

Italy2 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Oncologica Azienda Ospedaliera Universitaria Senese

    Siena, 53100

Other trials in Italy

Netherlands2 sites

  • NKI

    Amsterdam, 1066 CX

  • Radboudumc

    Nijmegen, HP 452

Other trials in Netherlands

About this study

Official title: Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (Formerly Known as CB1158) as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

Read the detailed description

This study is an open-label Phase 1 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

Single Agent INCB001158:

Patients with advanced/metastatic solid tumors will be enrolled into escalating monotherapy dose cohorts to determine the Recommended Phase 2 Dose (RP2D) of INCB001158. Additional patients with NSCLC, Colorectal Cancer (CRC), and other tumors including SCCHN, RCC, Gastric, Bladder and Melanoma will be enrolled at the single agent RP2D.

Combination Treatment:

Patients with advanced/metastatic NSCLC, Melanoma, Urothelial, Microsatellite Instability (MSI)/ Microsatellite Stable (MSS) CRC, Gastric, SCCHN and Mesothelioma will be enrolled into separate cohorts of combination therapy (INCB001158 and Pembrolizumab) to determine the RP2D.

In the dose expansion phase, additional patients with NSCLC, Melanoma, Urothelial, MSI/MSS CRC, Gastric, SCCHN and Mesothelioma will be treated with the combination of INCB001158 and Pembrolizumab at the RP2D.

All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.

Being tested
INCB001158, Pembrolizumab
Keywords
Immuno-Oncology, Checkpoint Inhibitors, Tumor Metabolism, Programmed cell death protein-1 (PD-1) inhibitor, Programmed death ligand 1 (PD-L1) inhibitor, Solid Tumors, RCC, MEL, NSCLC, Arginase, Arginase Inhibitor, INCB001158 (CB-1158), SCCHN, GEJ, Immune Therapy
Medical subject headings
Neoplasm Metastasis, Colorectal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Mesothelioma

What participants receive

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

  • INCB001158Drug

    Also called CB-1158

    Arginase Inhibitor

  • PembrolizumabDrug

    Also called Keytruda

    PD-1 Inhibitor

Study groups in NCT02903914
Study groupRoleWhat they receive
INCB00158 was administered as monotherapy at 50mg twice dailyExperimentalMonotherapy Part 1a: INCB001158 administered orally in patients with advanced/metastatic solid tumors. Escalating doses will be explored to determine the recommended phase 2 dose (RP2D).
Receives: Drug: INCB001158
INCB00158 was administered as monotherapy at 75mg twice dailyExperimentalMonotherapy Part 2a: INCB001158 administered orally at the RP2D in patients with advanced/metastatic NSCLC (EGFR and Anaplastic Lymphoma Kinase (ALK) negative) previously treated with Standard of Care (SOC).
Receives: Drug: INCB001158
INCB00158 was administered as monotherapy at 100mg twice dailyExperimentalMonotherapy Part 2b: INCB001158 administered orally at the RP2D in patients with advanced/metastatic CRC previously treated with SOC.
Receives: Drug: INCB001158
INCB00158 was administered as monotherapy at 150mg twice dailyExperimentalMonotherapy Part 2c: INCB001158 administered orally at the RP2D in patients with Bladder Cancer, Gastric or Gastroesophageal Junction (GEJ) Cancer, Renal Cell Cancer (RCC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Urothelial Cell Cancer (UCC), or Melanoma, previously treated with SOC.
Receives: Drug: INCB001158
INCB00158 was administered in combination with pembroluzimab at 50mg twice dailyExperimentalMonotherapy Part 2d: INCB001158 administered orally at the RP2D in patients with any tumor types in Parts 2a, 2b, or 2c.
Receives: Drug: INCB001158
INCB00158 was administered in combination with pembroluzimab at 75mg twice dailyExperimentalCombination Part 1b: INCB001158 and Pembrolizumab administered in patients with advanced/metastatic NSCLC, Melanoma, Urothelial Cell Cancer, MSI CRC, MSS CRC, Gastric or Gastroesophageal Junction (GEJ) Cancer, SCCHN and Mesothelioma. Multiple dose levels will be explored to determine the recommended phase 2 dose (RP2D).
Receives: Drug: INCB001158; Drug: Pembrolizumab
INCB00158 was administered in combination with pembroluzimab at 100mg twice dailyExperimentalPart 3a: INCB001158 and Pembrolizumab the combination RP2D in patients with advanced/metastatic NSCLC (EGFR and ALK negative) with disease progression on anti-PD-1 therapy or prolonged stable disease on Pembrolizumab in the immediate prior line of therapy.
Receives: Drug: INCB001158; Drug: Pembrolizumab
INCB001158 50 mg BID in combination with pembrolizumabExperimentalPart C: evaluated a reduced dose of INCB001158 50 mg BID in combination with pembrolizumab with patients with moderately impaired renal function.
Receives: Drug: INCB001158; Drug: Pembrolizumab

What is being measured

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

  1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.

    Measured: up to study completion (up to approximately 3.5 years)

Secondary outcomes (30)

  1. Recommended Phase 2 Dose (RP2D) of INCB001158

    The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.

    Measured: 12 weeks

  2. RP2D of INCB001158 in Combination With Pembrolizumab

    INCB001158 was dosed orally BID.

    Measured: 12 weeks

  3. Objective Response Rate (ORR)

    ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.

    Measured: Until disease progression/study discontinuation (up to approximately 5 years)

  4. Percentage of Participants With the Indicated Best Overall Response (BOR)

    BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.

    Measured: Until disease progression/study discontinuation (up to approximately 5 years)

  5. Duration of Response (DOR)

    DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.

    Measured: Until disease progression/study discontinuation (up to approximately 5 years)

  6. Progression-free Survival (PFS)

    PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.

    Measured: Until disease progression/study discontinuation (up to approximately 5 years)

  7. Cmax of INCB001158 Following Single Escalating Doses for Part 1A

    Cmax was defined as the maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  8. Tmax of INCB001158 Following Single Escalating Doses for Part 1A

    tmax was defined as the time of the maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  9. AUC0-t of INCB001158 Following Single Escalating Doses for Part 1A

    AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  10. AUC0-inf of INCB001158 Following Single Escalating Doses for Part 1A

    AUC0-inf was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 extrapolated to infinity.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  11. t1/2 of INCB001158 Following Single Escalating Doses for Part 1A

    t1/2 was defined as the half-life of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  12. CL/F of INCB001158 Following Single Escalating Doses for Part 1A

    CL/F was defined as the apparent oral dose clearance of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  13. Vz/F of INCB001158 Following Single Escalating Doses for Part 1A

    Vz/F was defined as the apparent volume of distribution of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

  14. Cmax of INCB001158 Following Multiple Escalating Doses for Part 1A

    Cmax was defined as the maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  15. Tmax of INCB001158 Following Multiple Escalating Doses for Part 1A

    tmax was defined as the time of the maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  16. AUC0-t of INCB001158 Following Multiple Escalating Doses for Part 1A

    AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  17. AUC0-tau of INCB001158 Following Multiple Escalating Doses for Part 1A

    AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  18. t1/2 of INCB001158 Following Multiple Escalating Doses for Part 1A

    t1/2 was defined as the half-life of INCB001158.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  19. CL/F of INCB001158 Following Multiple Escalating Doses for Part 1A

    CL/F was defined as the apparent oral dose clearance of INCB001158.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  20. Vz/F of INCB001158 Following Multiple Escalating Doses for Part 1A

    Vz/F was defined as the apparent volume of distribution of INCB001158.

    Measured: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

  21. Cmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food

    Cmax was defined as the maximum observed concentration of INCB001158.

    Measured: Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

  22. Tmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food

    tmax was defined as the time of the maximum observed concentration of INCB001158.

    Measured: Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

  23. AUC of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food

    AUC was defined as the area under the concentration-time curve of INCB001158.

    Measured: Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

  24. Cmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

    Cmax was defined as the maximum observed concentration of INCB001158.

    Measured: Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose

  25. Tmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

    tmax was defined as the time of the maximum observed concentration of INCB001158.

    Measured: Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose

  26. AUC0-t of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

    AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.

    Measured: Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose

  27. AUC0-tau of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

    AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.

    Measured: Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose

  28. Cmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)

    Cmax was defined as the Maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.

  29. Tmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)

    tmax was defined as the time of the maximum observed concentration of INCB001158.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.

  30. AUC0-8h of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)

    AUC0-8h was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to 8 hours post-dose.

    Measured: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

Timeline

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

  1. First posted16 Sep 2016 (estimated)
  2. Study start14 Sep 2016
  3. Primary completion30 Apr 2020
  4. Study completion15 Aug 2022

Resources

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
Factorial
Masking
None (open label)
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02903914
Sponsor's protocol ID
INCB 01158-101
Other IDs
Mk3475 Keynote 741, 2017-002903-82, 2017
Status last verified
Aug 2025
First submitted
9 Sep 2016
Last updated
5 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Naing A, Papadopoulos KP, Pishvaian MJ, Rahma O, Hanna GJ, Garralda E, Saavedra O, Gogov S, Kallender H, Cheng L, Smith M, Chen X, Kuriakose E, Bauer T. First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours. BMJ Oncol. 2024 May 9;3(1):e000249. doi: 10.1136/bmjonc-2023-000249. eCollection 2024.

    PubMed 39886141

  • Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.

    PubMed 39462179

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB001158 and Pembrolizumab in people with Metastatic Cancer and Solid Tumors, run by Incyte Corporation at 20 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 10 inclusion and 23 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Spain, Italy, 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 30 Sep 2021). 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?

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to study completion (up to approximately 3.5 years)). 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 NCT02903914, which also lists 2 linked publications.

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 5 Aug 2025.

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