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

NCT ID: NCT03886831

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2022-11-16

Brief Summary

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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

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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 ten 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.

Conditions

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Relapsed/Refractory Advanced Solid Tumors Relapsed/Refractory Diffuse Large B-cell Lymphoma Relapsed/Refractory Myelodysplasia Relapsed/Refractory Myelofibrosis Adenoid Cystic Carcinoma Relapsed/Refractory Mantle Cell Lymphoma Relapsed/Refractory Acute Myeloid Leukemia Refractory Chronic Myelomonocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRT543

PRT543 will be administered orally

Group Type EXPERIMENTAL

PRT543

Intervention Type DRUG

PRT543 will be administered orally

Interventions

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PRT543

PRT543 will be administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prelude Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

UCSF Precision Cancer Medicine Building

San Francisco, California, United States

Site Status

Christiana Care Health Services, Christiana Hospital

Newark, Delaware, United States

Site Status

Florida Cancer Specialists

Lake Mary, Florida, United States

Site Status

Florida Cancer Specialist

Sarasota, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

The Ohio State University and Wexner Medical Center

Columbus, Ohio, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

PLLC

Nashville, Tennessee, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PRT543-01

Identifier Type: -

Identifier Source: org_study_id

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