MedPacto gets FDA OK for colorectal cancer drug clinical trial
Yoo-Rim Kim
Jan 03, 2024 (Gmt+09:00)
South Korea's biotech company MedPacto Inc. announced on Tuesday that it has got approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a combination therapy using Vactosertib and pembrolizumab (product name: Keytruda)
This trial will focus on patients previously undergoing metastatic colorectal cancer treatment.
It is a phase 2b/3 trial designed to assess the efficacy of the combination therapy with Vactosertib and Pembrolizumab.
The primary endpoint for this trial will be overall survival (OS). The trial is planned as a multi-national effort, including South Korea and the US locations.
MedPacto will conduct this trial with the support of Pembrolizumab provided free of charge by Merck (MSD), under a clinical trial collaboration and supply agreement.