A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumours

Official Title

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumours

Summary:

This study is being conducted to assess the safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, and checkpoint inhibitor relapsed tumours

Trial Description

Primary Outcome:

• Safety and tolerability of EDP1503 alone and in combination with pembrolizumab as assessed per CTCAE v5.0
• Safety and tolerability of EDP1503 alone and in combination with pembrolizumab
• Evidence of anti-tumour activity of EDP1503 based on ORR

Secondary Outcome:

• Progression Free Survival
• Overall Survival

This will be a Phase I/II open-label study which will involve a 2-week monotherapy with EDP1503, following which the patients will be dosed with a combination of EDP1503 and pembrolizumab.

View this trial on ClinicalTrials.gov