Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas
Verified date | April 2023 |
Source | Prelude Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | March 28, 2023 |
Est. primary completion date | March 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Cancer Center at Augusta University | Augusta | Georgia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | The Ohio State University and Wexner Medical Center | Columbus | Ohio |
United States | Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Florida Cancer Specialists | Lake Mary | Florida |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Yale- New Haven Hospital- Yale Cancer Center | New Haven | Connecticut |
United States | Christiana Care Health Services, Christiana Hospital | Newark | Delaware |
United States | Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania |
United States | Washington University School of Medicine - Siteman Cancer Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Prelude Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To describe dose limiting toxicities (DLT) of PRT811 | Dose limiting toxicities will be evaluated through the first cycle | Baseline through Day 21 | |
Primary | To determine the maximally tolerated dose (MTD) | The MTD will be established for further investigation in participants with solid tumors and gliomas | Baseline through approximately 2 years | |
Primary | To determine the recommended phase 2 dose (RP2D) and schedule of PRT811 | The RP2D will be established for further investigation in participants with solid tumors and gliomas | Baseline through approximately 2 years | |
Secondary | To describe the adverse event profile and tolerability of PRT811 | Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy | Baseline through approximately 2 years | |
Secondary | To describe the pharmacokinetic profile of PRT811 | PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration | Cycle 1 (each cycle is 21 days) on Days 1, 8 and 14. For subsequent cycles, Day 1 of each cycle through the end of study treatment, an average of 6 months | |
Secondary | To describe any anti-tumor activity of PRT811 | Anti-tumor activity of PRT811 will be based on the measurement of objective responses | Baseline through approximately 2 years |
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