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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT04764474
Trial Phases:	Phase I	Protocol IDs:	2020-306-GLOB1 (primary) NCI-2021-03247
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hutchmed
NCI Full Details:	http://clinicaltrials.gov/show/NCT04764474

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.

Objectives

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

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