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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03886831

Run by

Prelude Therapeutics

People needed

232

Starts

2019-02-11

Expected to finish

2022-11-16

Last updated by the study team

2023-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• UCSF Precision Cancer Medicine Building — San Francisco, California, United States
• Christiana Care Health Services, Christiana Hospital — Newark, Delaware, United States
• Florida Cancer Specialists — Lake Mary, Florida, United States
• Florida Cancer Specialist — Sarasota, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Atlantic Health System / Morristown Medical Center — Morristown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• The Ohio State University and Wexner Medical Center — Columbus, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• PLLC — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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