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NCT05107856 · ClinicalTrials.gov registry record · Phase 1
PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies
A Phase 1 study, sponsored by Prelude Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT05107856: Clinical Trial Phase 1 study, sponsored by Prelude Therapeutics.
NCT05107856 is a Phase 1 study that was terminated before completion, run by Prelude Therapeutics. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05107856, a Phase 1 study, was terminated before completion, sponsored by Prelude Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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).
Primary Outcome
Dose limiting toxicities will be evaluated over the 28-day observation period
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG PRT1419
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 1 |
Why NCT05107856 stopped before completion
NCT05107856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT05107856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05107856 about?
NCT05107856 is a clinical study titled "PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies". 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 eithe...
What is the current status of trial NCT05107856?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2022-03-22. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT05107856?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), PRT1419 (DRUG).
Who is sponsoring clinical trial NCT05107856?
This trial is sponsored by Prelude Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05107856's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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