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

Last updated: April 3, 2023
Sponsor: Prelude Therapeutics
Overall Status: Completed

Phase

1

Condition

Neurofibromatosis

Brain Tumor

Cancer

Treatment

N/A

Clinical Study ID

NCT04089449
PRT811-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Malignancies that are refractory to or intolerant of established therapies known toprovide clinical benefit for the malignancy in question, or in the opinion of theInvestigator, not be a candidate for such therapies
  • Subjects must have recovered from the effects of any prior investigational systemtherapies
  • 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 atleast 2 cycles of adjuvant temozolomide chemotherapy. Mutant Glioma must comply withbiomarker 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 7days of the start of treatment and must agree to use an effective method ofcontraception during the trial

Exclusion

Exclusion Criteria:

  • Untreated concurrent malignancies or malignancies that have been in complete remissionfor less than one year
  • Treatment with strong inhibitors of CYP3A4 for which there are no therapeuticsubstitutions
  • Inflammatory disorders of the gastrointestinal tract, or subjects with GImalabsorption
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT811

Study Design

Total Participants: 86
Study Start date:
November 06, 2019
Estimated Completion Date:
March 28, 2023

Study 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.

Connect with a study center

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • Yale- New Haven Hospital- Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Care Health Services, Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Florida Cancer Specialists

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • The Ohio State University and Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

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