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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.