Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the first patient has been dosed in the U.S. clinical trial of its independently developed novel CDH17-targeting antibody-drug conjugate (ADC) (R&D code: 7MW4911) for the treatment of advanced colorectal cancer and other advanced gastrointestinal tumors.

The Phase I/II study (NCT07216560) represents the first-in-human (FIH) study of 7MW4911 in the United States. The trial aims to evaluate the safety, pharmacokinetics and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors. Previously, 7MW4911 received clinical trial approval and completed first patient dosing in China.

7MW4911 is a novel CDH17-targeting ADC developed by Mabwell based on its proprietary IDDC™ platform. It is composed of a highly specific CDH17 monoclonal antibody capable of efficient internalization into tumor cells, a novel cleavable linker with high plasma stability, and a proprietary DNA topoisomerase I inhibitor payload, MF-6, specifically designed to overcome the multidrug resistance.

Preclinical studies demonstrated that 7MW4911 exhibited potent antitumor activity in CDX/PDX models of various gastrointestinal tumors. In multidrug-resistant models, its antitumor effect was significantly superior to MMAE/DXd-based ADCs, and it was able to reverse tumor progression following treatment with such ADCs, highlighting its advantage in treating resistant tumors. Relevant research findings have been published in the 2025 AACR and the internationally renowned journal Cell Reports Medicine (July 2025).