Phase 1 Study of Oral HMPL-506 for Treating Blood Cancers Including AML, ALL, and Multiple Myeloma Evaluating Safety, Dosage, and Effectiveness in Adults

What this Trial Is About

Researchers are conducting a Phase 1, open-label, multicenter clinical study to evaluate the safety, pharmacokinetics, and preliminary efficacy of HMPL-506 in patients with hematological malignancies. The study focuses on patients with specific genetic alterations in blood cancers, including relapsed or refractory Acute Myeloid Leukemia AML, Acute Lymphocytic Leukemia ALL, and multiple myeloma MM. The trial is sponsored by Hutchmed and aims to enroll between 60 and 132 patients across two phases dose escalation and dose expansion. In the dose escalation phase, approximately 30 to 38 patients with MLL-rearranged andor NPM1-mutant relapsedrefractory AML or ALL will receive escalating oral doses of HMPL-506 once daily. Starting at 50 mg, doses may increase based on safety, efficacy, and pharmacokinetic data, with adjustments guided by a Safety Monitoring Committee. The dose expansion phase will enroll about 30 to 60 patients divided into three cohorts based on specific genetic markers or disease type. Patients in this phase will receive the recommended phase 2 dose in 28-day cycles until disease progression, unacceptable toxicity, or other study endpoints. Participants will undergo regular assessments including bone marrow aspiration and biopsy, safety monitoring for dose-limiting toxicities and adverse events, and evaluations of anti-tumor efficacy every treatment cycle. Pharmacokinetic and pharmacodynamic analyses will be conducted, along with electrocardiograms and laboratory tests. Safety follow-up will continue up to 42 months after the last dose. The study includes monitoring for serious adverse events and overall survival, with participants remaining under medical supervision throughout the trial duration.

A Clinical Study of HMPL-506 in Patients With Hematological Malignancies