NCT05107856

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 Injection as Monotherapy or in Combination With Azacitidine or Venetoclax in Patients With Relapsed/Refractory Myeloid or B-cell Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Prelude Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia-1 (MCL-1) inhibitor, in participants with selected relapsed/refractory myeloid or B-cell malignancies. The purpose of this study is to evaluate the safety and tolerability of PRT1419 monotherapy and in combination with either azacitidine or venetoclax, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Detailed description

This is a multicenter, open-label, dose-escalation, Phase 1 study of PRT1419, a MCL-1 inhibitor, evaluating participants with acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), MDS/myeloproliferative neoplasm (MPN) overlap syndrome, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and B-cell non-hodgkin lymphoma (NHL) including marginal zone lymphoma, follicular lymphoma or mantle cell lymphoma. Participants in study will receive PRT1419 as monotherapy or in combination with either Azacitidine (AZA) or Venetoclax (VEN). The study includes multiple dose escalations and expansion cohorts for RP2D confirmation.

Conditions

• Acute Myeloid Leukemia
• B-cell Non-Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia
• Chronic Myelomonocytic Leukemia
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Myelodysplastic Syndromes
• Myeloproliferative Neoplasm
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	PRT1419	PRT1419 will be administered by intravenous infusion
DRUG	Azacitidine	Azacitidine will be administered by intravenous or subcutaneous
DRUG	Venetoclax	Venetoclax will be administered orally

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2021-11-04
• Last updated: 2024-01-31

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study