A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    90
  • sponsor
    Hutchison Medipharma Limited
Updated on 3 June 2021

Summary

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

Description

HMPL-306 is a dual IDH1/2 inhibitor

This is a phase 1, open-label, multicenter study to evaluate the safety and tolerability of HMPL-306 administered orally in the treatment of subjects with advanced or metastatic solid tumors with IDH mutation. The study consists of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). The dose escalation part will determine the MTD/RP2D. The dose expansion part will administer the MTD/RP2D to mIDH-positive solid tumor malignancies including, but not limited to, cholangiocarcinoma, skeletal chondrosarcoma, low-grade glioma, perioperative low-grade glioma

Details
Condition Isocitrate Dehydrogenase Gene Mutation
Treatment HMPL-306
Clinical Study IdentifierNCT04762602
SponsorHutchison Medipharma Limited
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects are eligible for enrollment into this study if they meet any of the
following criteria (NOTE: This is not an exhaustive list)
Subjects aged 18 years
ECOG performance status 0 or 1
Subjects must have a documented IDH mutation per immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor tissue
Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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