Hutchison China MediTech Limited has initiated a Phase II study of HMPL-453. This novel small molecule inhibitor targets fibroblast growth factor receptors (“FGFR”) in patients with advanced malignant mesothelioma.
The clinical study is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in confirmed patients with advanced malignant mesothelioma that failed at least one line of systemic therapy in the past.
The primary outcome measure is overall response rate. Secondary outcome measures include preliminary efficacy such as disease control rate, time to response, duration of response, progression-free survival, and overall survival. The lead investigator for this study is Shun Lu, Professor at Shanghai Chest Hospital at Jiao Tong University. Additional details on this trial can be found at clinicaltrials.gov using identifier NCT04290325.
About Fibroblast Growth Factor Receptors
FGFRs are a sub‑family of the receptor tyrosine kinases. Activating of FGFR signaling pathways is central to several biological processes. In normal physiology, FGF/FGFR signaling is involved in embryonic development, tissue repair, angiogenesis, neuroendocrine, and metabolism homeostasis. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, and conferring resistance to anti‑tumor treatments.
HMPL‑453 is a new, highly selective and potent small molecule inhibitor that targets fibroblast growth factor receptors 1, 2, and 3. In pre‑clinical studies, HMPL‑453 demonstrated superior potency and better kinase selectivity compared to other drugs in its same class, as well as a favorable safety profile. Enrollment has been completed for the dose escalation of the Phase I study of HMPL-453 in China. Additional details on this can be found at clinicaltrials.gov, using identifier NCT03160833.