HUTCHMED Launches Global Phase I Study of KRAS-EGFR Antibody-Targeted Therapy HMPL-A830 for Solid Tumors

Stock News
09/28

HUTCHMED (00013) announced the commencement of the Phase Ia portion of a global clinical trial evaluating HMPL-A830 for the treatment of unresectable advanced or metastatic solid tumors.

The first patient received their initial dose in China on September 24, 2026.

Antibody-targeted conjugate drugs (ATTCs) use antibody-guided delivery to concentrate potent, cell-killing targeted payloads on tumor tissue, where they exert their activity. This first-in-class ATTC candidate is created by conjugating a highly selective, potent KRAS (Kirsten rat sarcoma) small molecule inhibitor as the payload with an anti-epidermal growth factor receptor (EGFR) antibody.

Colorectal cancer, pancreatic cancer, and lung cancer are the cancer types with the highest incidence of KRAS gene alterations, and these patients often lack safe and durable KRAS therapies. HMPL-A830 is designed to address this need by delivering the KRAS inhibitor directly to tumors expressing EGFR, simultaneously blocking both the EGFR and KRAS signaling pathways, thereby enhancing efficacy, durability, and tolerability.

This first-in-human trial is a Phase I, open-label, multicenter clinical study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of HMPL-A830. The study includes a Phase Ia dose-escalation stage to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE). A subsequent dose-expansion/optimization stage will further assess the safety, tolerability, and preliminary anti-tumor activity of HMPL-A830 in selected solid tumors. Additional details of the study can be found on clinicaltrials.gov under registration number NCT07718581.

On September 3, 2026, the company's subsidiary Hutchison MediPharma (Shanghai) Co., Ltd. (HUTCHMED Limited) entered into an exclusive development and licensing agreement with a subsidiary of GSK plc (referred to as "GlaxoSmithKline"), granting that GSK subsidiary the rights to develop and commercialize HMPL-A830 globally, excluding Mainland China, Hong Kong, Macau, and Taiwan. Hutchison MediPharma (Shanghai) Co., Ltd. will be responsible for the global Phase I development program of HMPL-A830. The GSK subsidiary will be responsible for all subsequent clinical development and commercialization activities outside Mainland China, Hong Kong, Macau, and Taiwan. The agreement's effectiveness is subject to the satisfaction of customary closing conditions, including the completion of relevant antitrust regulatory reviews.

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