Trial | NCT03886831  Report issue

Title

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    PRT543

  • Study Participants

    232
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.
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.
Study Started
Feb 11
2019
Primary Completion
Nov 16
2022
Study Completion
Nov 16
2022
Last Update
Mar 28
2023

Drug PRT543

PRT543 will be administered orally

PRT543 Experimental

PRT543 will be administered orally

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
No Results Posted