Mabwell Initiates First Clinical Trial of Novel Cancer Treatment 7MW4911 in the U.S.

Mabwell's Groundbreaking Clinical Trial for Advanced Colorectal Cancer Using 7MW4911

Mabwell, a biopharmaceutical company based in Shanghai, has recently taken a significant step in the fight against advanced colorectal cancer and other gastrointestinal tumors by initiating a clinical trial for its innovative antibody-drug conjugate (ADC), known as 7MW4911. This trial marks a critical milestone as it is the first-in-human study of the drug in the United States, following its earlier approval and first patient dosing in China.

Study Overview

The Phase I/II trial, which is registered under the clinical trial number NCT07216560, seeks to evaluate the safety, pharmacokinetics, and efficacy of 7MW4911 in patients suffering from advanced colorectal and other gastrointestinal cancers. The study's primary goals include determining how well the drug is tolerated and its effectiveness in targeting tumor cells that aggressively resist available treatments.

7MW4911 utilizes Mabwell’s proprietary IDDC™ platform to create a highly specific CDH17-targeting monoclonal antibody. This design facilitates efficient delivery of a potent payload directly into the tumor cells, potentially overcoming challenges posed by multidrug resistance that complicate treatment for many patients.

Mechanism of Action

The ADC combines a monoclonal antibody that specifically binds to the CDH17 protein expressed in tumor cells, a novel linker with outstanding stability in the bloodstream, and a proprietary DNA topoisomerase I inhibitor called MF-6. This strategic design is primarily focused on enhancing the therapeutic index of the treatment, significantly improving results for patients who have not responded well to conventional therapies.

Preclinical studies have demonstrated compelling antitumor activity in models of various gastrointestinal tumors, outmatching existing ADCs that rely on MMAE/DXd. Notably, 7MW4911 has shown an ability to reverse tumor progression after treatment with these less effective agents, underscoring its potential role in managing drug-resistant tumors—a critical area of need in oncology.

Prior Research and Findings

Mabwell has published relevant research findings in esteemed journals, including the 2025 American Association for Cancer Research (AACR) proceedings and the international journal Cell Reports Medicine in July 2025. These studies not only convey the promising results from preclinical evaluations but also foreshadow a potential paradigm shift in treating resistant tumors with targeted therapies like 7MW4911.

About Mabwell

Founded with a mission to innovate within the pharmaceutical industry, Mabwell operates on the vision of enhancing patient health through groundbreaking therapies. The company champions the exploration of new life-saving drugs, with a specific focus on oncology and age-related diseases. With a fully integrated industry chain and a commitment to tackling global health challenges, Mabwell is working to bring transformative solutions to patients worldwide.

As the clinical trials progress, Mabwell remains committed to its goals of providing effective and accessible treatment options amidst the ever-evolving landscape of cancer therapies. For updates on this clinical trial and further developments, interested parties are encouraged to visit Mabwell's official website at www.mabwell.com/en.