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

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, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies

Brief Summary

      This is a Phase 1 cohort, dose-escalation, dose-expansion 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, dose-expansion 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 involving up to nine 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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

To describe dose limiting toxicities (DLT) of PRT543

Secondary Outcome

 To describe the adverse event profile and tolerability of PRT543

Condition

Relapsed/Refractory Advanced Solid Tumors

Intervention

PRT543

Study Arms / Comparison Groups

 PRT543

Description:  PRT543 will be administered orally

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

227

Start Date

February 11, 2019

Completion Date

August 11, 2022

Primary Completion Date

August 11, 2021

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, acute myeloid
             leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All
             malignancies must be refractory to established therapies

          -  Biomarker-selected solid tumors

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 615-329-7274, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03886831

Organization ID

PRT543-01

Responsible Party

Sponsor

Study Sponsor

Prelude Therapeutics

Study Sponsor

, , 

Verification Date

April 2021