Myelodysplastic Syndrome Clinical Trial
A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
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.
Full 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 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.
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, 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
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There are 22 Locations for this study
Gilbert Arizona, 85234, United States
San Francisco California, 94158, United States
Newark Delaware, 19718, United States
Lake Mary Florida, 32746, United States
Sarasota Florida, 34232, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Morristown New Jersey, 07962, United States
Bronx New York, 10467, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
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