MedPacto gets FDA OK for colorectal cancer drug clinical trial

It will carry out the Phase 2b/3 clinical trial to evaluate the efficacy of Vactosertib and Pembrolizumab combination therapy

MedPacto gets FDA OK for colorectal cancer drug clinical trial
Yoo-Rim Kim 1
2024-01-03 11:27:31 youforest@hankyung.com
Bio & Pharma

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.

Write to Yoo-Rim Kim at youforest@hankyung.com

MedPacto's anti-cancer substance designated as US FDA fast-track item

MedPacto's anti-cancer substance designated as US FDA fast-track item

South Korean biotech company MedPacto Inc. ’s Vactosertib monotherapy for osteosarcoma patients has been designated as a fast-track development item by the US Food and Drug Administration."Following last year's rare pediatric disease designation (RPDD), the latest fast-track designation

Korea’s MedPacto, Merck plan phase 3 trials of colorectal cancer drug

Korea’s MedPacto, Merck plan phase 3 trials of colorectal cancer drug

Drugmaker Merck & Co Inc. MedPacto Inc., a South Korean biotechnology company that develops therapeutics for cancer and autoimmune diseases, has agreed with global drugmaker Merck & Co Inc. to jointly conduct phase 3 clinical trials of their respective cancer treatments in combination.U

(* comment hide *}