HUTCHMED (China) Limited today announces that it has initiated a Phase Ib/II study in China of HMPL-453, an investigational novel selective inhibitor targeting fibroblast growth factor receptors (“FGFR”) 1/2/3, in combination with chemotherapy or the anti-PD-1 therapy, toripalimab. The first patient received their first dose on January 22, 2022.

The clinical trial is a multi-center, two-stage, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-453 combination therapy in patients with specific advanced or metastatic solid tumors.

The first stage of the study is a dose escalation phase to determine the dose limiting toxicity (DLT) and recommended Phase II dose (“RP2D”) of HMPL-453 in combination with chemotherapy (gemcitabine and cisplatin) or toripalimab. The second stage of the study is a dose expansion phase in solid tumor patients with either gastric cancer, intrahepatic cholangiocarcinoma, or urothelial carcinoma, harboring specific FGFR gene alterations. Each solid tumor cohort will be treated with a specific combination of HMPL-453 and a chemotherapy or anti-PD-1 therapy to further evaluate the preliminary efficacy, safety and tolerability at the RP2D.

A Phase II study of HMPL-453 monotherapy is also underway in patients with advanced intrahepatic cholangiocarcinoma (IHCC) in China (clinicaltrials.gov identifier NCT04353375).

About HMPL-453

HMPL-453 is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth (through tissue growth and repair), promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings.

HUTCHMED currently retain all rights to HMPL-453 worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/​immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China