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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07617363
The ClinicalTrials.gov registry entry for NCT07617363 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT07617363 reports 0 study locations.
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.
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