A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations.
Primary Objectives:
Part 1: To evaluate the safety and tolerability of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations
Part 2: To characterize safety and tolerability, and to determine RP2D of HMPL-306 in subjects with locally advanced hematological malignancies that harbor IDH mutations
Secondary Objectives:
1. To assess preliminary antitumor activity of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations
2. To assess the PK of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations.
3. To assess PD of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Neil Palmisiano MD
- Principal Investigator
Key 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.
Key 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 >38.3°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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.