Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

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 PRMT5 PRMT5 Inhibitor Lymphoma Leukemia Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Hematologic Neoplasms Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Carcinoma, Adenoid Cystic PRT543

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCSF Precision Cancer Medicine Building accepting new patients
    San Francisco California 94158 United States
  • Banner MD Anderson Cancer Center accepting new patients
    Gilbert Arizona 85234 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Prelude Therapeutics
ID
NCT03886831
Phase
Phase 1
Study Type
Interventional
Last Updated