Adagene Doses First Patient in Phase 2 Trial of Muzastotug Plus KEYTRUDA for MSS Colorectal Cancer
Adagene Inc. has initiated a Phase 2 clinical trial for muzastotug (ADG126) combined with KEYTRUDA® in patients with microsatellite stable colorectal cancer. The trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with a primary endpoint of overall response rate. Completion is anticipated by early 2027, with updates expected from an ongoing Phase 1b/2 trial. The trial designs align with US FDA requirements.
Adagene Inc. has announced the initiation of a randomized, open-label Phase 2 clinical trial evaluating muzastotug (ADG126) in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with microsatellite stable colorectal cancer (MSS CRC) without liver metastases. The study will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with up to 30 patients per arm. The primary endpoint for the Phase 2 trial is overall response rate (ORR). The company anticipates completing the trial in early 2027, with additional updates and data from the ongoing Phase 1b/2 trial-previously reported at ASCO 2025-expected in the coming months. Both Phase 2 and planned Phase 3 trial designs and endpoints were previously aligned with the US FDA. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adagene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9565588-en) on October 31, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
