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A Study of PRT811 in Participants With Advanced Solid Tumors 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.
 
ClinicalTrials.gov Identifier: NCT04089449
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : June 4, 2020
Sponsor:
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 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 and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors 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.

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Study Type : Interventional
Estimated Enrollment : 125 participants
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 and Recurrent High-Grade Gliomas
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Biomarker-selected solid tumors
  • 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT04089449


Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Study Contact    615-329-7274    CANN.REFMAL655@SarahCannon.com   
United States, Delaware
Christiana Care Health Services, Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Study Contact    615-329-7274    CANN.REFMAL655@SARAHCANNON.COM   
United States, Ohio
The Ohio State University and Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Study Contact    615-329-7274    CANN.REFMAL655@SARAHCANNON.COM   
United States, Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Study Contact    615-329-7274    CANN.REFMAL655@SarahCannon.com   
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Study Contact    615-329-7274    CANN.REFMAL655@SarahCannon.com   
Sponsors and Collaborators
Prelude Therapeutics
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Responsible Party: Prelude Therapeutics
ClinicalTrials.gov Identifier: NCT04089449    
Other Study ID Numbers: PRT811-01
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue