Back to resultsA Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
Primary Purpose
Advanced Solid Tumor, Recurrent Glioma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRT811
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor focused on measuring PRMT5, PRMT5 Inhibitor
Eligibility Criteria
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
Sites / Locations
- Sarah Cannon Research Institute at HealthONE
- Yale- New Haven Hospital- Yale Cancer Center
- Christiana Care Health Services, Christiana Hospital
- Florida Cancer Specialists
- Georgia Cancer Center at Augusta University
- Northwestern Memorial Hospital
- University of Iowa Hospitals and Clinics
- Washington University School of Medicine - Siteman Cancer Center
- The Ohio State University and Wexner Medical Center
- Thomas Jefferson University, Sidney Kimmel Cancer Center
- Tennessee Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRT811
Arm Description
PRT811 will be administered orally
Outcomes
Primary Outcome Measures
To describe dose limiting toxicities (DLT) of PRT811
Dose limiting toxicities will be evaluated through the first cycle
To determine the maximally tolerated dose (MTD)
The MTD will be established for further investigation in participants with solid tumors and gliomas
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
Secondary Outcome Measures
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
To describe the pharmacokinetic profile of PRT811
PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration
To describe any anti-tumor activity of PRT811
Anti-tumor activity of PRT811 will be based on the measurement of objective responses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04089449
Brief Title
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prelude Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Recurrent Glioma
Keywords
PRMT5, PRMT5 Inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRT811
Arm Type
Experimental
Arm Description
PRT811 will be administered orally
Intervention Type
Drug
Intervention Name(s)
PRT811
Intervention Description
PRT811 will be administered orally
Primary Outcome Measure Information:
Title
To describe dose limiting toxicities (DLT) of PRT811
Description
Dose limiting toxicities will be evaluated through the first cycle
Time Frame
Baseline through Day 21
Title
To determine the maximally tolerated dose (MTD)
Description
The MTD will be established for further investigation in participants with solid tumors and gliomas
Time Frame
Baseline through approximately 2 years
Title
To determine the recommended phase 2 dose (RP2D) and schedule of PRT811
Description
The RP2D will be established for further investigation in participants with solid tumors and gliomas
Time Frame
Baseline through approximately 2 years
Secondary Outcome Measure Information:
Title
To describe the adverse event profile and tolerability of PRT811
Description
Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Time Frame
Baseline through approximately 2 years
Title
To describe the pharmacokinetic profile of PRT811
Description
PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration
Time Frame
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
Title
To describe any anti-tumor activity of PRT811
Description
Anti-tumor activity of PRT811 will be based on the measurement of objective responses
Time Frame
Baseline through approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Yale- New Haven Hospital- Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Care Health Services, Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Florida Cancer Specialists
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Washington University School of Medicine - Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Ohio State University and Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
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A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
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