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Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Intrahepatic Cholangiocarcinoma in China

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 03, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors (“FGFR”), in patients with advanced intrahepatic cholangiocarcinoma (“IHCC”), which is a type of liver cancer.
The clinical study is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in patients with advanced IHCC with FGFR2 fusion that had failed at least one line of systemic therapy.The primary outcome measure is objective response rate (ORR).  Secondary outcome evaluations include preliminary efficacy measures, such as disease control rate (DCR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).  Additional details may be found at clinicaltrials.gov, using identifier NCT04353375.About IHCC
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