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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: Hutchison Medipharma Limited
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 hematological malignancies including,
but not limited to, AML, MDS/MPN, AITL.
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