Status:
COMPLETED
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
Lead Sponsor:
Prelude Therapeutics
Conditions:
Advanced Solid Tumor
Recurrent Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available trea...
Detailed Description
This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options inc...
Eligibility Criteria
Inclusion
- Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies
- Subjects must have recovered from the effects of any prior investigational system therapies
- For subjects with recurrent high-grade glioma or GBM, must have biopsy proven evidence (WHO Grade III or IV) and received external bean fractionated radiotherapy and at least 2 cycles of adjuvant temozolomide chemotherapy. Mutant Glioma must comply with biomarker defined enrollment criterias.
- For biomarker-selected solid tumors: must meet enrollment criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial
Exclusion
- Untreated concurrent malignancies or malignancies that have been in complete remission for less than one year
- Treatment with strong inhibitors of CYP3A4 for which there are no therapeutic substitutions
- Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
- HIV positive; known active hepatitis B or C
- Known hypersensitivity to any of the components of PRT811
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04089449
Start Date
November 6 2019
End Date
March 28 2023
Last Update
April 5 2023
Active Locations (11)
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1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
2
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, United States, 06510
3
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, United States, 19718
4
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746