Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

Study Overview
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Brief Summary
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This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

Official Title
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A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors

Conditions
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Cervical Cancer, Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer

Intervention / Treatment
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* Drug: Q702
* Biological: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy of at least 3 months Exclusion Criteria: A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis Has had an allogeneic tissue/solid organ transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation of Q702 in combination with fixed dose of pembrolizumab<br>Give one week on/one week off at selected dose level | Drug: Q702<br>* The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.<br>Biological: Pembrolizumab<br>* Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle<br>* Other names: KEYTRUDA®;|
| Experimental: Dose expansion of Q702 in combination with fixed dose of pembrolizumab<br>Give intravenously once every three week at 200 mg | Drug: Q702<br>* The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.<br>Biological: Pembrolizumab<br>* Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle<br>* Other names: KEYTRUDA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE |  | Up to approximately 2 years (Each Cycle is 42 Days) | 
| Tumor response using RECIST version 1.1 throughout study |  | Up to approximately 2 years (Each Cycle is 42 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the area under curve (AUC) of Q702 and its primary metabolites |  | Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days) |