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

  • STATUS
    Recruiting
  • End date
    Aug 11, 2022
  • participants needed
    227
  • sponsor
    Prelude Therapeutics
Updated on 7 August 2021

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.

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.

Details
Condition Adenocarcinoma, Adenoid Cystic Carcinoma, Refractory Chronic Myelomonocytic Leukemia, Malignant Adenoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma or Mantle Cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma or Mantle Cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Advanced Solid Tumors, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelodysplasia, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Myelofibrosis, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Acute Myeloid Leukemia
Treatment PRT543
Clinical Study IdentifierNCT03886831
SponsorPrelude Therapeutics
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

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
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Biomarker-selected solid tumors
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
Clear my responses

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