On February 4, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported 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 (Press release, Hutchison China MediTech, FEB 4, 2022, View Source [SID1234607754]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.