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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: IN_REVIEW
San Francisco
University of California San Francisco
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Varun Monga
Phone: 319-384-9497

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Eytan M. Stein
Phone: 212-639-3314

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Prelude Therapeutics

  • Primary ID PRT543-01
  • Secondary IDs NCI-2019-04424
  • Clinicaltrials.gov ID NCT03886831