Akeso's AK157D1 ADC Cleared for Phase I Solid Tumor Trial
Akeso, Inc. has received clearance from China's CDE to initiate a Phase I clinical trial for its investigational B7-H3-targeting antibody-drug conjugate, AK157D1. The trial will focus on solid tumors.

Akeso, Inc. announced it has received clearance from the Center for Drug Evaluation (CDE) in China to proceed with a Phase I clinical trial for its investigational antibody-drug conjugate (ADC), AK157D1. The trial will investigate the drug's potential in treating solid tumors.
AK157D1 targets the B7-H3 protein, which is known to be overexpressed in a variety of cancer types, including breast, lung, and prostate cancers. This clearance marks the third ADC developed by Akeso to enter clinical trials, further diversifying the company's oncology pipeline.
The company is actively developing other ADCs, with AK117 (targeting CD20) and AK107 (targeting EGFR) already in clinical development. The addition of AK157D1 to its clinical portfolio signals Akeso's ongoing commitment to advancing novel cancer therapies.
The primary objectives of the Phase I trial are to evaluate the safety, tolerability, and determine the recommended dosage of AK157D1 in adult patients with advanced solid tumors. The results from this initial study will inform the subsequent stages of the drug's development.