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A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04089449
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : August 1, 2022
Information provided by (Responsible Party):
Prelude Therapeutics

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Recurrent Glioma CNS Lymphoma Drug: PRT811 Phase 1

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, CNS lymphoma, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: PRT811
PRT811 will be administered orally
Drug: PRT811
PRT811 will be administered orally

Primary Outcome Measures :
  1. To describe dose limiting toxicities (DLT) of PRT811 [ Time Frame: Baseline through Day 21 ]
    Dose limiting toxicities will be evaluated through the first cycle

  2. To determine the maximally tolerated dose (MTD) [ Time Frame: Baseline through approximately 2 years ]
    The MTD will be established for further investigation in participants with solid tumors and gliomas

  3. To determine the recommended phase 2 dose (RP2D) and schedule of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    The RP2D will be established for further investigation in participants with solid tumors and gliomas

Secondary Outcome Measures :
  1. To describe the adverse event profile and tolerability of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy

  2. To describe the pharmacokinetic profile of PRT811 [ 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 ]
    PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration

  3. To describe any anti-tumor activity of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    Anti-tumor activity of PRT811 will be based on the measurement of objective responses

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 lymphoma with CNS involvement: must have relapsed or refractory CNS lymphoma, adequate bone marrow reserves and at least one lesion measurable for response using the appropriate response criteria for the type of lymphoma.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04089449

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Contact: Study Contact 615-329-7274

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United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Yale- New Haven Hospital- Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Services, Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
United States, Florida
Florida Cancer Specialists Recruiting
Lake Mary, Florida, United States, 32746
United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Ohio State University and Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Prelude Therapeutics
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Responsible Party: Prelude Therapeutics Identifier: NCT04089449    
Other Study ID Numbers: PRT811-01
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prelude Therapeutics:
PRMT5 Inhibitor
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue