NCT04768686

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

A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	FLX475	tablet
DRUG	Pembrolizumab	IV infusion

Timeline

• Start date: 2021-05-18
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2021-02-24
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

10 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study