HUTCHMED (00013) initiates global research on PI3K/PIKK-EGFR ATTC candidate drug HMPL-A580 for the treatment of solid tumors.

HUTCHMED (00013) announced today that HUTCHMED has initiated a Phase I/IIa clinical trial in China and the United States for its second Antibody-Drug Conjugate (ATTC) HMPL-A580 for the treatment of unresectable advanced or metastatic solid tumors. The first patient received their first dose of treatment on March 4, 2026. HMPL-A580 is a globally first-in-class ATTC, consisting of a highly selective and potent PI3K/PIKK small molecule inhibitor as the payload, linked to an anti-EGFR antibody through a cleavable linker. This is the second ATTC candidate drug developed by HUTCHMED based on this highly innovative PI3K/PIKK inhibitor payload. EGFR is widely known to be an important driver of tumor initiation and progression as it is overexpressed in various solid tumors. Preclinical data shows that inhibition of the PAM pathway has synergistic effects with anti-EGFR therapy, enhancing anti-tumor activity. The results will be presented at an upcoming scientific conference. This first-in-human trial is a Phase I/IIa, open-label, multicenter clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of HMPL-A580. The study is divided into two stages. In the dose escalation phase of Phase I, patients will receive HMPL-A580 intravenously at predetermined doses to determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE). The subsequent dose expansion/optimization phase of Phase IIa will further evaluate the safety, tolerability, and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors, and determine the recommended dose for the next phase.