Status:
RECRUITING
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
Lead Sponsor:
Qurient Co., Ltd.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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, hepatocellu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05438420
Start Date
January 12 2023
End Date
June 30 2026
Last Update
March 12 2024
Active Locations (7)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
3
CHA Bundang Medical Center
Seongnam-si, South Korea
4
Asan Medical Center
Seoul, South Korea