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(Alliance News) - Hutchmed China Ltd said on Friday it has begun phase one B/phase two studies of its HMPL-453 drug in China.
The Hong Kong-based biopharmaceutical company said the trial will evaluate HMPL-453, its investigational novel selective inhibitor which targets fibroblast growth factor receptors, in combination with chemotherapy drugs, or the anti-PD-1 therapy toripalimab.
It will evaluate the safety, tolerability, pharmacokinetics - meaning, how the concentration of a dosed drug in body fluids and tissues changes with time - as well as preliminary efficacy of HMPL-453 as a combination therapy for patients with specific advanced or metastatic tumours.
The first stage will determine the dose limiting toxicity and the recommended dose for the second stage in combination with chemotherapy drugs or toripalimab. The second stage will give a specific combination of the drugs to solid tumour patients, and evaluate the preliminary efficacy, safety and tolerability.
A phase two study is also being conducted in China on HMPL-453 as a monotherapy in patients with advanced intrahepatic cholangiocarcinoma, a rare type of primary liver cancer.
Hutchmed retains all rights to HMPL-453 worldwide.
The company's share price was down 1.2% to 387.42 pence each in London on Friday morning.
By Elizabeth Winter; elizabethwinter@alliancenews.com
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