NCT04764474

A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH

A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies With Isocitrate Dehydrogenase (IDH) Mutations

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations.

Detailed description

HMPL-306 is a dual IDH1/2 inhibitor This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 administered orally in treatment of subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations (or co-mutations). The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). The dose-escalation part will determine the MTD/R2PD. The dose-expansion part will administer the MTD/RP2D to subjects with mIDH-positive AML

Conditions

• Isocitrate Dehydrogenase Gene Mutation

Interventions

Type	Name	Description
DRUG	HMPL-306	Administered orally QD in a 28-day continuous dosing treatment cycle

Timeline

• Start date: 2021-04-12
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2021-02-21
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

15 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study