CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
FLX475 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04768686
NCT04768686Phase 2Completed

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

Hanmi Pharmaceutical Company Limited·interventional·Posted Feb 24, 2021·Updated Sep 25, 2025

In Brief

A Phase 2 clinical trial evaluating FLX475 and Pembrolizumab for Gastric Cancer. Completed, enrolled 20 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesSouth Korea

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 24, 2021
Enrollment StartMay 18, 2021
Primary CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.4 years ago

Interventions

FLX475drug

tablet

Pembrolizumabdrug

IV infusion