Clinical Trials /

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

NCT03886831

Description:

This is a Phase 1 cohort, dose-escalation study of PRT543 in patients with advanced cancers 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 PRT543.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Malignant Solid Tumor
  • Mantle Cell Lymphoma
  • Myelodysplastic Syndromes
  • Myelofibrosis
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
  • Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: PRT543-01
  • NCT ID: NCT03886831

Conditions

  • Relapsed/Refractory Advanced Solid Tumors
  • Relapsed/Refractory Diffuse Large B-cell Lymphoma or Mantle Cell Lymphoma
  • Relapsed/Refractory Myelodysplasia
  • Relapsed/Refractory Myelofibrosis

Interventions

DrugSynonymsArms
PRT543PRT543

Purpose

This is a Phase 1 cohort, dose-escalation study of PRT543 in patients with advanced cancers 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 PRT543.

Detailed Description

      This is a multicenter, open-label, sequential-cohort, dose-escalation Phase 1 study of PRT543
      in patients with advanced cancers who have exhausted available treatment options. Enrollment
      will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas
      and one for hematological malignancies). The study will consist of 2 parts, a dose escalation
      part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion
      part with four separate cohorts. For patients, 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 PRT543.
    

Trial Arms

NameTypeDescriptionInterventions
PRT543ExperimentalPRT543 will be administered orally
  • PRT543

Eligibility Criteria

        Inclusion Criteria:

          -  Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or
             advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome; or relapsed
             myelofibrosis. All malignancies must be refractory to established therapies

          -  Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1

          -  Adequate organ function (bone marrow, hepatic, renal, cardiovascular)

          -  Female patients 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:

          -  Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases

          -  Requirement of pharmacologic doses of glucocorticoids

          -  Prior treatment with chimeric antigen receptor T cells (CAR-T cells)

          -  HIV positive; known active hepatitis B or C

          -  Known hypersensitivity to any of the components of PRT543

          -  Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less
             than 100 days since transplantation
      
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 PRT543
Time Frame:Baseline through Day 28.
Safety Issue:
Description:Dose limiting toxicities (DLTs) will be evaluated during the first cycle

Secondary Outcome Measures

Measure:To describe the adverse event profile and tolerability of PRT543
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 determine the maximum observed plasma concentration (Cmax) of PRT543
Time Frame:Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
Safety Issue:
Description:PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration.
Measure:To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543
Time Frame:Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
Safety Issue:
Description:PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration

Details

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

Last Updated

August 29, 2019