By Fineline Cube China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study for HMPL-A83, its monoclonal antibody (mAb) targeting CD47, in patients with advanced malignant tumors. The first patient was dosed on July 15, 2022.
Study Details
The multi-center, open-label Phase I trial (NCT05429008) will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HMPL-A83. Primary endpoints include dose-limiting toxicity (DLT), safety, tolerability, Phase II recommended dose (RP2D), and maximum tolerated dose (MTD). Secondary endpoints cover pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy.
Mechanism and Preclinical Data
CD47 is highly expressed in various tumors and plays a role in immune escape by inhibiting macrophage-mediated phagocytosis. HMPL-A83 blocks CD47’s binding to SIRPα, disrupting cancer cells’ immune evasion. Preclinical studies showed HMPL-A83 had low red blood cell binding, no agglutination, and strong antitumor activity in animal models, with high affinity for tumor cell CD47.-Fineline Info & Tech