MedPacto announced on Jan. 2 that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for the combination therapy of Vactosertib and Pembrolizumab (commercially known as Keytruda).
This clinical trial targets patients with previously treated metastatic colorectal cancer. It is a Phase 2b/3 trial to assess the efficacy of the combination therapy of Bactosertib and Pembrolizumab, with overall survival as the primary endpoint. The trial will be conducted as a multinational clinical study including sites in the United States and South Korea.
MedPacto will carry out this clinical trial in collaboration with Merck (MSD), receiving Pembrolizumab free of charge as per the clinical trial cooperation and supply agreement.
A representative from MedPacto expressed optimism, stating, “If the trial is successful, it is expected to provide a new treatment option for patients with metastatic colorectal cancer who currently lack adequate therapies.”