AP Biosciences has received Bellberry Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a Phase 1 study evaluating AP402, a potential first-in-class bispecific antibody designed to target p95HER2 and concurrently engage CD137 (4-1BB) to activate T cells, in patients with trastuzumab-resistant HER2-positive cancers. The Phase 1 clinical trial, currently taking place in Australia, is designed to evaluate the safety, tolerability, and preliminary efficacy of AP402 in patients with advanced solid tumors, including HER2-positive breast cancer.
12.18 2024
AP Biosciences Receives Approval from Australia HRECs for Phase 1 Clinical Trial of AP402
AP402 has received approval and CTN clearance from the HREC and TGA in Australia to initiate Phase 1/2 clinical trials.
