Tanja Obradovic, Senior Advisor of Oncology Drug Development at HopeAI, Consultant, Oncology Drug Development at Arc Nouvel Clinical Development Consulting, and Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“First Antibody-Targeted Therapy Conjugate Enters Clinical Development-Possibility for New Revolutionary Approach to Taming Cancer
Phase Ⅰ/Ⅱa study of HMPL-A251, a first antibody-targeted therapy conjugate (ATTC) targeting anti-HER2 with PI3K/PIKK inhibitor as its payload, in patients with advanced HER2-expressing solid tumors (NCT07228247) has been posted and is planned for start by the end of this month.
HMPL-A251 is developed by Hutchmed as a first-in-class ATTC comprising of this highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker, designed to address challenges by enhancing targeted delivery directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure. Preclinical package indicates superior or comparable efficacy in multiple tumors compared to well established HER2 targeting ADC Enhertu (by AstraZeneca and Daiichi). Read more.
This new mechanism of action matters as ADC with cytotoxic payload increasingly raise safety profile concerns while possibility for increased efficacy via multiple specific targeting is opened. Phase I/II HMPL-A251 trial will be recruiting 147 patients at 11 sites across USA and China. Oncology community is certain to closely follow progress in 2026. Also, spotlight will be on dynamics of additional ATTC entering clinical development announced recently by Hutchmed.”
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