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NCT05253131 · ClinicalTrials.gov registry record · Phase 2
Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT05253131: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT05253131 is a Phase 2 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05253131, a Phase 2 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.
Primary Outcome
To determine the safety, tolerability, and recommended doses of selumetinib given in combination with ZEN-3694 in participants with refractory sarcomas including MPNST. The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of selumetinib in combination with ZEN-3694 will be determined based on dose-limiting toxicities (DLTs) observed during the first cycle of therapy. DLTs are defined as grade ≥3 toxicities attributable to the study drugs, assessed according to CTCAE v5. Dose esc
Interventions
- COMBINATION_PRODUCT Selumetinib + ZEN-3694 ± Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2026-05-15 |
| Est. Completion | 2032-05-15 |
| Phase | Phase 2 |
What is known before NCT05253131 opens enrollment
NCT05253131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Selumetinib + ZEN-3694 ± Durvalumab is the first listed.
NCT05253131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05253131 about?
NCT05253131 is a clinical study titled "Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas". A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion ...
What is the current status of trial NCT05253131?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2026-05-15. Estimated completion is 2032-05-15.
What interventions are being tested in trial NCT05253131?
The interventions under investigation include: Selumetinib + ZEN-3694 ± Durvalumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05253131?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05253131's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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