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

Last updated: March 8, 2024
Sponsor: Qurient Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Gastric Cancer

Pelvic Cancer

Treatment

Q702

Pembrolizumab

Clinical Study ID

NCT05438420
QRNT-008
MK-3475-D35 (KEYNOTE-D35)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant (or legally acceptable representative if applicable) provides writteninformed consent for the trial.
  • Subjects with histologically or cytologically confirmed advanced or metastaticesophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed ontreatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered eitheras monotherapy, or in combination with other therapies
  • Have measurable disease per RECIST v 1.1. as assessed by local siteinvestigator/radiology
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 3 months

Exclusion

Exclusion Criteria:

  • A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatmentor breast-feeding women
  • Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5within the timeline duration of five half-lives prior to starting study drug andthroughout the trial
  • Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timelineduration 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 hada history of radiation pneumonitis
  • Has had an allogeneic tissue/solid organ transplant

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Q702
Phase: 1/2
Study Start date:
January 12, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • CHA Bundang Medical Center

    Seongnam-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

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