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Hutchmed (China) (0013) said it has initiated the phase Ia part of a global clinical trial of HMPL-A830 in patients with unresectable, advanced, or metastatic solid tumors.
The first patient received the first dose in China on Thursday, the company said.
This first-in-class antibody-targeted therapy conjugate (ATTC) drug candidate comprises a highly selective and potent Kirsten rat sarcoma (KRAS) small molecule inhibitor payload conjugated to an anti-epidermal growth factor receptor (EGFR) antibody, it said.
An ATTC enables tumor-specific activity of potent, cell-killing, targeted therapy payloads by leveraging antibody-guided delivery. Colorectal, pancreatic and lung cancers have the highest incidence of patients with KRAS-altered tumors, who often lack a safe and durable KRAS therapy.
HMPL-A830 is designed to address this need by delivering a KRAS inhibitor directly to
EGFR-expressing tumors, while simultaneously blocking EGFR and KRAS signaling to enhance efficacy, durability, and tolerability, Hutchmed said.
This first-in-human, multicenter, open-label Phase I clinical study evaluates the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HMPL-A830, it noted.
The current study consists of a Phase Ia dose escalation part to determine the maximum tolerated dose and recommended dose for expansion, the drugmaker said, adding that the subsequent dose expansion/optimization part is to further characterize its safety, tolerability and preliminary anti-tumor activity in selected solid tumors.