NCT04762602

A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations

A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of HMPL-306 in Subjects With Locally Advanced or Metastatic Solid Tumors With IDH Mutations

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (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 advanced or metastatic solid tumors with IDH mutation.

Detailed description

HMPL-306 is a dual IDH1/2 inhibitor This is a phase 1, open-label, multicenter study to evaluate the safety and tolerability of HMPL-306 administered orally in the treatment of subjects with advanced or metastatic solid tumors with IDH mutation. The study consists of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). The dose escalation part will determine the MTD/RP2D. The dose expansion part will administer the MTD/RP2D to mIDH-positive solid tumor malignancies including, but not limited to, cholangiocarcinoma, skeletal chondrosarcoma, low-grade glioma, perioperative low-grade glioma

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: 2021-02-28
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2021-02-21
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

11 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study