Clincosm LogoSign in Get a demo

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

Sponsor
Qurient Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05438420
Collaborator
Merck Sharp & Dohme LLC (Industry)
120
Enrollment
2
Arms
44
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
Anticipated Study Start Date :
Oct 30, 2022
Anticipated Primary Completion Date :
Oct 30, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-related adverse events as assessed by CTCAE [Up to approximately 2 years (Each Cycle is 42 Days)]

    2. Tumor response using RECIST version 1.1 throughout study [Up to approximately 2 years (Each Cycle is 42 Days)]

    Secondary Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qurient Co., Ltd.
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qurient Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05438420
    Other Study ID Numbers:
    • QRNT-008
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Neoplasms
    Carcinoma, Hepatocellular
    Pembrolizumab

    Study Results

    No Results Posted as of Jun 30, 2022