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

Active:	No
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT04762602
Trial Phases:	Phase I	Protocol IDs:	2020-306-GLOB2 (primary) NCI-2021-01982
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hutchmed
NCI Full Details:	http://clinicaltrials.gov/show/NCT04762602

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.

Objectives

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

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