Status:
TERMINATED
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
Lead Sponsor:
Hutchmed
Conditions:
Isocitrate Dehydrogenase Gene Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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 \>38.3°C 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
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04762602
Start Date
February 28 2021
End Date
February 27 2025
Last Update
September 16 2025
Active Locations (11)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Kentucky
Lexington, Kentucky, United States, 40536