NCT07025018

Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations

A Multicenter, Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HMPL-306 in Patients With Gliomas Harboring IDH1 and/or IDH2 Mutations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations

Detailed description

HMPL-306 is a dual IDH1/2 inhibitor. This is a multicenter, randomized controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations. The study consists of 2 parts: Part 1 (safety lead-in phase) and Part 2 (perioperative phase). Part 1 will determine safety and DLT. Part 2 will administer the HMPL-306 or no treatment to mIDH-positive gliomas.

Conditions

• Gliomas Harboring IDH1 and/or IDH2 Mutations

Interventions

Type	Name	Description
DRUG	HMPL-306	IDH small molecule inhibitor

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-06-17
• Last updated: 2025-08-01

Locations

1 site across 1 country: China