The open-label, multi-centre study will assess the preliminary efficacy, pharmacokinetics, tolerability and safety of the investigational HMPL-415.
It intends to recruit up to 80 patients, some of whom will be part of the dose escalation stage, as well as more patients at the determined recommended Phase II dose (RP2D).
Dr Tianshu Liu of Zhongshan Hospital Fudan University and Dr Nong Yang of Hunan Cancer Hospital will act as the trial’s principal investigators.
HMPL 415 is a new selective allosteric inhibitor that targets protein tyrosine phosphatase-2 containing the Src homology-2 domain (SHP2), which is found mainly in the cytoplasm of several tissues.
This protein modulates various cell signalling events that control cell migration, differentiation, oncogenic transformation, transcription, cell growth and metabolism.
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When stimulated by cytokines and growth factors, SHP2 regulates key signalling events such as RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases.
The dysregulation in expression or activity in SHP2 leads to several developmental diseases, as well as haematological and solid tumours.
HUTCHMED currently holds global rights to HMPL-415. The company’s oncology drug portfolio consists of three drugs that are being marketed in China.
In addition to oncology drugs, HUTCHMED develops immunotherapeutic and targeted therapies for treating immunological diseases.
The company employs more than 5,000 colleagues across its operations, including around 1,800 in oncology and immunology.
Earlier this year, HUTCHMED completed enrolling participants in a Phase III ESLIM-01 trial of sovleplenib to treat primary immune thrombocytopenia (ITP) in China.
The randomised, double-blinded study is intended to evaluate sovleplenib’s efficacy and safety in a total of 188 adult ITP patients.
Durable response rate is the trial’s primary endpoint.