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21 August 2026: Akeso’s AK157D1 cleared for phase 1 trial in Solid tumors
- Akeso announced that its B7-H3-targeted ADC candidate AK157D1 has been cleared by China’s NMPA Center for Drug Evaluation to enter phase 1 clinical development for the treatment of patients with advanced solid tumors, adding a third differentiated ADC after AK146D1, AK138D1 to the company’s clinical-stage pipeline
- The phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of AK157D1 in patients with advanced solid tumors, supporting the clinical assessment of the candidate’s therapeutic potential
- The program targets a broad range of solid tumors with high B7-H3 expression, including lung, prostate, esophageal, colorectal and breast cancers, addressing the significant unmet need for effective targeted therapies across these tumor types
- AK157D1 is a B7-H3-directed ADC that uses a site-specific conjugation strategy to link a topoisomerase I inhibitor DXd payload to a monoclonal antibody through an MC-AAA linker, designed to enable targeted delivery of the cytotoxic payload to B7-H3-expressing tumor cells
- Strategically, the clinical clearance further expands Akeso’s differentiated ADC pipeline and strengthens its presence in the increasingly competitive B7-H3 ADC landscape, while creating opportunities to evaluate AK157D1 both as a monotherapy and in combination with the company’s immuno-oncology assets
