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February 7, 2022

Hutchmed begins Phase Ib/II trial of solid tumour combo therapy

The trial will assess the tolerability, safety, pharmacokinetics and initial efficacy profile of HMPL-453 combination therapy.

Hutchmed has commenced a Phase Ib/II clinical trial of the investigational therapy, HMPL-453, along with chemotherapy or toripalimab for advanced solid tumours in China.

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The first subject in the trial was given the first dose last month.

HMPL-453 is an inhibitor that acts on targeting fibroblast growth factor receptors (FGFR) 1/2/3 while toripalimab is an anti-programmed cell death protein 1 (PD-1) therapy.

Chemotherapy will comprise gemcitabine and cisplatin.

The open-label, multicentre, two-stage trial will analyse the tolerability, safety, pharmacokinetics and initial efficacy profile of HMPL-453 combination treatment in particular advanced or metastatic solid tumour patients.

In the dose-escalation phase, the dose-limiting toxicity (DLT), as well as the recommended Phase II dose (RP2D) of HMPL-453 plus chemotherapy or toripalimab, will be established. 

The dose-expansion phase will be carried out in individuals with either gastric cancer, intrahepatic cholangiocarcinoma, or urothelial carcinoma, harbouring specific FGFR gene mutations. 

To further assess the initial safety, efficacy and tolerability at the RP2D, each solid tumour arm will be given a specific cocktail of HMPL‑453 and chemotherapy or anti-PD-1 treatment. 

Hutchmed noted that a Phase II trial of HMPL-453 as a single agent is progressing in advanced intrahepatic cholangiocarcinoma (IHCC) patients in the country.

At present, the company retains all rights to the therapy across the globe.

Last month, Hutchmed commenced a Phase I trial of HMPL-653 to treat advanced malignant solid tumours and tenosynovial giant cell tumours (TGCT) patients in the region.

This single-arm, open-label, multicentre trial will evaluate the safety, pharmacokinetics, tolerability and preliminary efficacy of HMPL-653, a colony-stimulating factor 1 receptor inhibitor.

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