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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04089449
Other study ID # PRT811-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 6, 2019
Est. completion date March 28, 2023

Study information

Verified date April 2023
Source Prelude Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.


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 including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PRT811
PRT811 will be administered orally

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Prelude Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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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