NEW YORK – Hutchmed has begun treating cancer patients in a Phase Ib/II trial of HMPL-453, in which it is evaluating the investigational FGFR1/2/3 inhibitor in combination with either chemotherapy or the PD-1 inhibitor toripalimab.
In the two-stage study, the Hong Kong-headquartered firm is assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of combination approaches with HMPL-453 in patients with advanced solid tumors. Hutchmed said the first patient in the study received treatment on Jan. 22.
In the first dose-escalation stage, Hutchmed will track patients for dose limiting toxicities and determine the recommended Phase II dose of HMPL-453 with gemcitabine and cisplatin or toripalimab. In the second dose-expansion stage, the firm will enroll patients with FGFR-altered intrahepatic cholangiocarcinoma as well as patients with gastric and urothelial cancer, and evaluate the efficacy, safety, and tolerability of the combination regimens at the recommended Phase II doses.
The immunotherapy toripalimab is a product of Coherus Biosciences, which is studying it in head and neck, lung, gastrointestinal, and other cancers in ongoing trials.
Hutchmed, meanwhile, is also studying HMPL-453 as a single agent in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions.