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

Sponsor: Qurient Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05438420

Patient View

This phase 1B/2 open-label study evaluates the safety and preliminary efficacy of Q702 with pembrolizumab in patients with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers. Eligible participants must have progressed on prior anti-PD1/PD-L1 therapy, have measurable disease, and an ECOG status of 0 or 1. Q702 is taken orally, while pembrolizumab is given via IV infusion.

Patient Parameters

Program Overview

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 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

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