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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    75
  • sponsor
    Hutchison Medipharma Limited
Updated on 26 April 2021

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.

Description

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.

Details
Condition Isocitrate Dehydrogenase Gene Mutation
Treatment HMPL-306
Clinical Study IdentifierNCT04764474
SponsorHutchison Medipharma Limited
Last Modified on26 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects may be enrolled in this study only if they satisfy all the following
criteria (NOTE: This is not an exhaustive list)
Subjects aged 18 years
ECOG performance status 2
Subjects with advanced relapsed, refractory, or resistant hematological malignancies, as defined below
Subjects with documented IDH mutation per local or institutional next generation sequence (NGS)
Subjects must be refractory to or intolerant of established therapies

Exclusion Criteria

Subjects are not eligible for enrollment into this study if they meet any of
the following criteria (NOTE: This is not an exhaustive list)
Subjects who received an investigational agent <14 days prior to their first day of study drug administration
Subjects who are pregnant or breastfeeding
Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever >38.3C during screening visits or on their first day of study drug administration
Subjects with some current or prior heart conditions
Subjects taking medications that are known to prolong the QT interval may not be eligible
Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
Some subjects with some current or prior gastrointestinal or liver diseases
Subjects with inadequate organ function as defined by the protocol
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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