The study will proceed in two phases aiming to enrol 60 to 98 patients with haematological malignancies. Credit: Nemes Laszlo / Shutterstock.

HUTCHMED has announced the initiation of a Phase I clinical trial of its menin inhibitor, HMPL-506, to potentially treat patients with haematological malignancies in China.

The first subject received the initial dose of the treatment on 31 May.

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This multicentre, open-label study is designed to assess the pharmacokinetics, safety, and efficacy of HMPL-506 when administered orally to patients with haematological malignancies.  

Aiming to enrol 60 to 98 patients, the study will proceed through two phases: a dose escalation phase followed by a dose expansion phase.

Eligibility for the study is contingent upon patients providing signed informed consent.

The dose escalation phase will include approximately 30 to 38 patients with mixed-lineage leukaemia (MLL)-rearranged and/or NPM1-mutant relapsed/refractory acute myeloid leukaemia (AML) and acute lymphocytic leukaemia (ALL).

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This phase will utilise an accelerated titration design with the modified toxicity probability interval-2 (mTPI-2) design for dose escalation and establishing the maximum tolerated dose (MTD).

Following the establishment of the recommended Phase II dose (RP2D) and/or MTD, the dose expansion phase will commence.

This phase will enrol 30 to 60 patients to further evaluate the safety, tolerability, and preliminary efficacy of HMPL-506.

Currently, there are no menin inhibitors approved globally.

HUTCHMED retains the complete rights to HMPL-506 across the globe.

The latest development comes after the company commenced a Phase II/III clinical trial of surufatinib in combination with other drugs as a first-line therapy for metastatic pancreatic ductal adenocarcinoma (PDAC) in China.

This treatment regimen includes surufatinib alongside camrelizumab from Jiangsu Hengrui Pharmaceuticals, as well as nab-paclitaxel and gemcitabine.

The first patient in the trial received their first dose on 8 May.

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