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A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations

Protocol No
HMP-2020-306-GLOB1
Principal Investigator
Ehab Atallah
Phase
I
Summary
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 patients with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations (or co-mutations) after at least 2 prior lines of therapies. 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 4 cohorts of patients: AML, MDS/MPN, AITL, and other mIDH-positive hematological malignancies.
Description
To evaluate the safety and tolerability of HMPL-306 in patients with advanced hematological malignancies that harbor IDH mutations and characterize safety and tolerability to determine RP2D of HMPL-306 in patients with advanced hematological malignancies that harbor IDH mutations.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL