drugset / Trial / NCT05107856
PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2022-03-22
- Primary completion
- 2024-01-19
- Completion
- 2024-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRT1419 | Unknown | — | Intravenous |
| Background | Azacitidine | Other / unclassified | — | Intravenous |
| Background | Venetoclax | Small molecule | — | Oral |