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

a study on Solid Tumor Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma Relapsed/Refractory Myelodysplasia Relapsed/Refractory Myelofibrosis Adenoid Cystic Carcinoma Mantle Cell Lymphoma Acute Myeloid Leukemia Leukemia Chronic Myelomonocytic Leukemia

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 nine 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 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
Contact us about this trial