Hutchmed has started a Phase I clinical trial to evaluate its investigational therapy, HMPL-653, for the treatment of patients with advanced malignant solid tumours and tenosynovial giant cell tumours (TGCT), in China.

The open-label, single-arm, multi-centre trial will assess the safety, pharmacokinetics, tolerability and preliminary efficacy of the new potent colony-stimulating factor 1 receptor (CSF-1R) inhibitor HMPL-653.

The dose escalation and expansion phase of the study is expected to recruit nearly 110 patients.

Dose limiting toxicity, tolerability, safety, recommended dose for the Phase II study and maximum tolerated dose are the primary goals of the study.

For this Phase I trial, pharmacokinetics, progression free survival, objective response rate are the secondary endpoints.

Other secondary goals include disease control rate and overall survival.

Jilin Cancer Hospital is serving as the lead institution for the study.

Hutchmed retains all rights to HMPL-653 across the globe at present. The therapy has been designed to act on malignant driven tumours as a single agent or along with other drugs.

Expressed usually on macrophages’ surface, CSF-1R attaches with its ligand CSF-1 and can promote growth and differentiation of macrophages.

Several studies have revealed that the tumour microenvironment could be modulated by blocking the CSF-1R signaling pathway. At present, no CSF-1R inhibitor has secured approval in China.

A rare type of soft tissue tumour, TGCT is caused due to abnormal proliferation and inflammation of giant cells, inflammatory cells and monocytes.

In July last year, Hutchmed initiated a Phase I trial of its investigational oral drug, HMPL‑295, to treat advanced malignant solid tumour patients.