Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq: HCM) (AIM: HCM) (HKEX: 13) announced on Wednesday that it has initiated a global Phase I/IIa clinical trial of its antibody-targeted therapy conjugate candidate HMPL-A580, with the first patient dosed on 4 March 2026.
The first-in-human, multicentre, open-label study is evaluating HMPL-A580 in patients with unresectable, advanced or metastatic solid tumours across China and the US. The trial will assess safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy, with an initial dose escalation phase followed by dose expansion to determine the recommended dose for further development.
HMPL-A580 is a first-in-class therapy combining a selective PI3K/PIKK inhibitor payload with an anti-EGFR antibody via a cleavable linker. The approach is designed to simultaneously inhibit the PI3K/AKT/mTOR pathway and EGFR signalling, with preclinical data indicating enhanced anti-tumour activity through this dual mechanism.
The candidate is the second programme from HUTCHMED's next-generation antibody-targeted therapy conjugate platform, which aims to improve tumour targeting and reduce off-target toxicity compared with traditional treatments.
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