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

• Status: Recruiting
• Trial end date: 2022-08-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prelude Therapeutics

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