Pharma Focus Asia

HUTCHMED Initiates Phase I Study of Novel SHP2 Inhibitor HMPL-415

Tuesday, July 11, 2023

HUTCHMED has announced the initiation of a Phase I clinical trial in China for HMPL-415. HMPL-415 is an investigational selective allosteric inhibitor designed to target Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2).

The Phase I study is a multi-centre, open-label trial that aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HMPL-415 as a standalone treatment in patients with advanced malignant solid tumours.

The trial is expected to enrol approximately 80 patients, including participants in the dose escalation stage, as well as additional patients at the recommended Phase II dose (RP2D) determined during the study.

The results from this study will help determine the appropriate dosage and inform the design of subsequent Phase II trials to further evaluate HMPL-415's potential as a therapeutic option for cancer patients.

HMPL-415 is a novel and highly potent allosteric inhibitor specifically designed to target SHP2. SHP2 is a non-receptor protein tyrosine phosphatase found in the cytoplasm of various tissues. It plays a crucial role in regulating numerous cell signalling processes involved in metabolism, cell growth, differentiation, cell migration, transcription, and oncogenic transformation.

SHP2 interacts with different molecules within the cell and modulates key signalling events, including pathways such as RAS/ERK, PI3K/AKT, JAK/STAT, and PD-1 downstream of various receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines. Dysregulation of SHP2 expression or activity has been implicated in developmental disorders, haematological malignancies, and solid tumours.

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