(RTTNews) – Adagene Inc. (ADAG) announced the initiation of an investigator-initiated Phase 2 clinical trial to evaluate the efficacy of ADG126 or muzastotug in combination with KEYTRUDA for patients with stage II or stage III colorectal cancer.
The trial, led by Dr. Yong Wei Peng, Senior Consultant at the National University Cancer Institute in Singapore, will assess the combination treatment in a neoadjuvant setting, with patients receiving high doses of ADG126 prior to surgery.
The study aims to evaluate the rate of Major Pathologic Response or MPR, defined as =10 percent residual viable tumor in the surgical specimen, as the primary endpoint.
Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability.
The trial will also investigate the pharmacodynamic effects of ADG126 and pembrolizumab on the tumor microenvironment and explore ADG126’s pharmacokinetic profile in tumor tissues, providing valuable insights into its mechanism of action.
With a growing body of evidence supporting the safety and efficacy of ADG126, this study represents a promising step forward in advancing immunotherapy treatments for colorectal cancer.
If successful, this trial could pave the way for a potential new treatment option for patients with colorectal cancer.
The study is expected to begin enrolling patients in April 2025, with primary results anticipated in mid-2027.
Currently, ADAG is trading at $2.09 up by 2.45 percent on the Nasdaq.
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