A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
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
1 other identifier
interventional
86
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2019
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 13, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedApril 5, 2023
April 1, 2023
3.4 years
September 11, 2019
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To describe dose limiting toxicities (DLT) of PRT811
Dose limiting toxicities will be evaluated through the first cycle
Baseline through Day 21
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
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 Outcomes (3)
To describe the adverse event profile and tolerability of PRT811
Baseline through approximately 2 years
To describe the pharmacokinetic profile of PRT811
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
To describe any anti-tumor activity of PRT811
Baseline through approximately 2 years
Study Arms (1)
PRT811
EXPERIMENTALPRT811 will be administered orally
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510, United States
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, 19718, United States
Florida Cancer Specialists
Lake Mary, Florida, 32746, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110, United States
The Ohio State University and Wexner Medical Center
Columbus, Ohio, 43210, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Related Publications (1)
Barry A, Samuel SF, Hosni I, Moursi A, Feugere L, Sennett CJ, Deepak S, Achawal S, Rajaraman C, Iles A, Wollenberg Valero KC, Scott IS, Green V, Stead LF, Greenman J, Wade MA, Beltran-Alvarez P. Investigating the effects of arginine methylation inhibitors on microdissected brain tumour biopsies maintained in a miniaturised perfusion system. Lab Chip. 2023 May 30;23(11):2664-2682. doi: 10.1039/d3lc00204g.
PMID: 37191188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
September 13, 2019
Study Start
November 6, 2019
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
April 5, 2023
Record last verified: 2023-04