Core Insights - Hutchison China MediTech Limited (HCM) has announced the initiation of global Phase I clinical development for HMPL-A251, a first-in-class PI3K/PIKK-HER2 antibody-drug conjugate (ADC) [1][2] - The study aims to evaluate the safety and efficacy of HMPL-A251 in adult patients with unresectable, HER2-expressing advanced or metastatic solid tumors [1] Group 1: Clinical Development - HMPL-A251 is the first candidate from HCM's next-generation ADC platform to enter clinical development [2] - The clinical trial will be conducted in the United States and China, with the first patient dosed on December 16, 2025 [1] - The study consists of a Phase I dose-escalation stage and a Phase IIa dose-expansion and optimization stage, focusing on safety, tolerability, and preliminary efficacy [1] Group 2: Mechanism and Innovation - HMPL-A251 utilizes a highly selective and potent PI3K/PIKK inhibitor as the payload, coupled with a humanized anti-HER2 IgG1 antibody via a cleavable linker [1][2] - This innovative approach aims to target HER2-expressing tumor cells precisely, potentially overcoming systemic toxicity and narrow therapeutic windows associated with traditional PI3K/PIKK inhibitors [2] - Preclinical data supporting the potential of the ADC platform were presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targeted Therapy and Cancer [2]
和黄医药启动ATTC候选药物HMPL-A251用于治疗实体瘤的全球临床开发