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

February 23, 2026 updated by: Qurient Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seongnam-si, South Korea
        • CHA Bundang Medical Center
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Severance Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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
Give one week on/one week off at selected dose level
Drug: Q702
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.
Biological: Pembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Other Names:
  • KEYTRUDA®
Experimental: Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Give intravenously once every three week at 200 mg
Drug: Q702
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.
Biological: Pembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Other Names:
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qurient Co., Ltd.

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QRNT-008
  • MK-3475-D35 (KEYNOTE-D35) (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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