A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
Completed · Phase 1
Conditions studied: Advanced Solid Tumor, Recurrent Glioma
In brief
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 treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.
Key facts
- Study ID
- NCT04089449
- Run by
- Prelude Therapeutics
- People needed
- 86
- Starts
- 2019-11-06
- Expected to finish
- 2023-03-28
- Last updated by the study team
- 2023-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Yale- New Haven Hospital- Yale Cancer Center — New Haven, Connecticut, United States
- Christiana Care Health Services, Christiana Hospital — Newark, Delaware, United States
- Florida Cancer Specialists — Lake Mary, Florida, United States
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
- The Ohio State University and Wexner Medical Center — Columbus, Ohio, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
- Tennessee Oncology — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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