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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Other Locations
Republic of Korea
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Qurient Clinical Trial Information
clinicaltrial_info@qurient.com
+82-31-8060-1610
Time Frame
Start Date: 2023-01-12
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Dose escalation of Q702 in combination with fixed dose of pembrolizumab
Give one week on/one week off at selected dose level
Experimental: Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Give intravenously once every three week at 200 mg
Sponsors
Leads: Qurient Co., Ltd.
Collaborators: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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