Approval Probability
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Adjusted LOA
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FLX475 · 1 trial · 1 indication
The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| FLX475 and pembrolizumab combination therapy | EXPERIMENTAL | * Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer |
| Name | Type | Description |
|---|---|---|
| FLX475 | DRUG | tablet |
| Pembrolizumab | DRUG | IV infusion |
Inclusion Criteria: * All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma * Patient must have one of the following diagnoses to be eligible for enrollment into cohorts: * Cohort 1: Checkpoint inhib...
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FLX475 is an investigational small molecule being studied for the treatment of gastric cancer. It is being evaluated in combination with pembrolizumab in patients with advanced or metastatic gastric cancer. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
FLX475 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastric cancer.
FLX475 is in Phase 2 clinical development. A Phase 2 trial has been completed, which studied the drug in combination with pembrolizumab in patients with advanced or metastatic gastric cancer. The drug remains investigational and has not received regulatory approval.
FLX475 has been studied in one clinical trial, identified as NCT04768686. This Phase 2 trial evaluated FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. The trial was conducted in South Korea and enrolled 20 participants aged 18 years and older.
FLX475 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for gastric cancer. A completed Phase 2 trial has evaluated the drug, but it has not yet received regulatory approval for any indication.
FLX475 is a small molecule being studied in a biomarker-selected patient population with gastric cancer. The Phase 2 trial enrolled patients with advanced or metastatic disease, and the study was designed to evaluate the drug's effects in this specific group.