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

Phase 1

Recruiting

• Conditions: Esophageal Cancer; Gastric Cancer; Hepatocellular Cancer; Cervical Cancer
• Interventions: Drug: Q702; Biological: Pembrolizumab

• Registration Number: NCT05438420
• Lead Sponsor: Qurient Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2023-01-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-10-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose escalation of Q702 in combination with fixed dose of pembrolizumab	Pembrolizumab	Give one week on/one week off at selected dose level
Dose expansion of Q702 in combination with fixed dose of pembrolizumab	Q702	Give intravenously once every three week at 200 mg
Dose expansion of Q702 in combination with fixed dose of pembrolizumab	Pembrolizumab	Give intravenously once every three week at 200 mg
Dose escalation of Q702 in combination with fixed dose of pembrolizumab	Q702	Give one week on/one week off at selected dose level

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (7)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

University of Southern California; 🇺🇸 Los Angeles, California, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States