Overview

FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below. - Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer - Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.
Phase:
Phase 2
Details
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab