Akeso Gains Clearance for Phase I Trial of Bispecific Cancer Drug
Akeso, Inc. has received clearance from China's NMPA to begin a Phase I clinical trial for its investigational bispecific antibody-drug conjugate, AK158D1, targeting EGFR and TROP2 in advanced solid tumors.
Hong Kong-based Akeso, Inc. announced it has secured clearance from China's National Medical Products Administration (NMPA) to commence a Phase I clinical trial for AK158D1. This drug candidate is a next-generation bispecific antibody-drug conjugate (ADC) designed to target both EGFR and TROP2 proteins.
The drug is intended for the treatment of patients with advanced solid tumors. AK158D1 represents Akeso's fourth ADC candidate to enter the clinical stage. The company is developing a portfolio of cancer therapies, and this clearance signifies progress in its pipeline.
Bispecific ADCs combine the targeting capability of antibodies with the potency of cytotoxic drugs. EGFR and TROP2 are commonly expressed on the surface of various cancer cells, including lung and breast cancers, making AK158D1 a potentially applicable therapy for a range of patients.
The Phase I trial will primarily assess the safety and tolerability of AK158D1 in a small group of patients. The study will also gather preliminary data on efficacy and determine appropriate dosing for future clinical development. Akeso views this as a key step in advancing new treatment options for cancer patients.