Clinical Trials /

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

NCT04089449

Description:

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers, high-grade gliomas and myelofibrosis 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.

Related Conditions:
  • Conventional Glioblastoma Multiforme
  • Malignant Glioma
  • Malignant Solid Tumor
  • Myelofibrosis
  • Myeloproliferative Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of PRT811 in Participants With Advanced Solid Tumors, Gliomas and Myelofibrosis
  • Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Relapsed/Refractory Myelofibrosis, Advanced Solid Tumors and Recurrent High-Grade Gliomas

Clinical Trial IDs

  • ORG STUDY ID: PRT811-01
  • NCT ID: NCT04089449

Conditions

  • Advanced Solid Tumor
  • Recurrent Glioma
  • Myelofibrosis

Interventions

DrugSynonymsArms
PRT811PRT811

Purpose

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers, high-grade gliomas and myelofibrosis 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 and /or high-grade gliomas, and relapsed/refractory
      myeloproliferative neoplasms [MPN]. 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, glioblastoma multiforme and myelofibrosis. 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.
    

Trial Arms

NameTypeDescriptionInterventions
PRT811ExperimentalPRT811 will be administered orally
  • PRT811

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

          -  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:

          -  Requirement of pharmacologic doses of glucocorticoids

          -  Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less
             than 100 days since transplantation

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To describe dose limiting toxicities (DLT) of PRT811
Time Frame:Baseline through Day 21
Safety Issue:
Description:Dose limiting toxicities will be evaluated through the first cycle

Secondary Outcome Measures

Measure:To describe the adverse event profile and tolerability of PRT811
Time Frame:Baseline through approximately 2 years
Safety Issue:
Description:Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Measure: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
Safety Issue:
Description:PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration
Measure:To describe any anti-tumor activity of PRT811
Time Frame:Baseline through approximately 2 years
Safety Issue:
Description:Anti-tumor activity of PRT811 will be based on the measurement of objective responses

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Prelude Therapeutics

Last Updated

November 7, 2019