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 with six 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 Information
Recruitment Status
Drug
Estimated Enrollment
160
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; 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03886831
Organization ID
PRT543-01
Responsible Party
Sponsor
Study Sponsor
Prelude Therapeutics
Study Sponsor
, ,
Verification Date
December 2020