Akeso announced that AK157D1, its investigational B7-H3-targeting antibody-drug conjugate (ADC), received clinical-trial clearance from China’s Center for Drug Evaluation under the National Medical Products Administration.
The clearance enables Akeso to begin a Phase I study in patients with advanced malignant solid tumors.
Akeso plans to evaluate AK157D1 in combination with its bispecific antibodies ivonescimab and cadonilimab, potentially supporting combination-based development strategies.
AK157D1 becomes Akeso’s third next-generation ADC to enter clinical development, following AK146D1, a TROP2/Nectin-4 ADC, and AK138D1, a HER3 ADC.
The ADC uses a humanized IgG1 antibody directed at B7-H3, a payload based on the topoisomerase I inhibitor Dxd, and a site-specific MC-AAA linker.
B7-H3 is expressed across multiple solid tumors—including lung, prostate, esophageal, nasopharyngeal, colorectal and breast cancers—while showing relatively limited expression in normal tissues.
The announcement is an early development milestone; Phase I testing will primarily assess safety, tolerability, pharmacokinetics and dose selection rather than establish efficacy.
Sources:
Akeso's AK157D1 (B7-H3 ADC) Cleared for Phase I Trial in Solid ...
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A B7H3-targeting antibody-drug conjugate in advanced solid tumors