Hutchison China MediTech HCM has initiated a Phase 1b/2 study of surufatinib combined with BeiGene Ltd's BGNE tislelizumab in patients with advanced solid tumors in the U.S. and Europe.
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- The open-label study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of the surufatinib and tislelizumab combination.
- The study consists of two parts:
- Dose-finding Part 1 will be conducted to determine the recommended Phase II dose ("RP2D") and the maximum tolerated dose of surufatinib/ tislelizumab combo in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to, standard therapies.
- Part 2 dose expansion will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib/tislelizumab combo in patients with specific types of advanced or metastatic solid tumors.
- Surufatinib is an oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor and fibroblast growth factor receptor. It inhibits both angiogenesis and colony-stimulating factor-1 receptor, regulating tumor-associated macrophages, promoting the body's immune response against tumor cells.
- Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.
- Price Action: HCM shares closed 0.1% higher at $28.04, and BGNE shares closed 5.8% lower at $335.39 on Tuesday.
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