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NCT07617363 · ClinicalTrials.gov registry record · Phase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
A Phase 1 study, sponsored by Washington University School of Medicine.
- Not yet
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT07617363: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT07617363 is a Phase 1 study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07617363, a Phase 1 study, has not yet begun recruiting, sponsored by Washington University School of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a single-center, open-label, phase I study with dose escalation and dose expansion testing the combination of ATRN-119 and decitabine in patients with TP53-mutated acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The dose escalation phase will enroll patients with previously untreated, relapsed, or refractory AML or HR-MDS, regardless of TP53 alteration status, with the primary objective of determining safety and tolerability of ATRN-119 plus decitabine. The dose expansion phase will only enroll patients with previously untreated AML or HR-MDS with a TP53 alteration, with the primary objective of identifying the recommended phase 2 dose (RP2D).
Interventions
- DRUG Decitabine
- DRUG ATRN-119
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2026-08-31 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 1 |
What is known before NCT07617363 opens enrollment
NCT07617363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT07617363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07617363 about?
NCT07617363 is a clinical study titled "ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS". This is a single-center, open-label, phase I study with dose escalation and dose expansion testing the combination of ATRN-119 and decitabine in patients with TP53-mutated acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The dose escalation phase will enroll patients wi...
What is the current status of trial NCT07617363?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2026-08-31. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07617363?
The interventions under investigation include: Decitabine (DRUG), ATRN-119 (DRUG).
Who is sponsoring clinical trial NCT07617363?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07617363's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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