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NCT07015853 · ClinicalTrials.gov registry record · Phase 2
ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
A Phase 2 study, sponsored by Stephen Shiao.
- Not yet
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT07015853: Clinical Trial Phase 2 study, sponsored by Stephen Shiao.
NCT07015853 is a Phase 2 study that has not yet begun recruiting, run by Stephen Shiao. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015853, a Phase 2 study, has not yet begun recruiting, sponsored by Stephen Shiao.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.
Primary Outcome
The proportion of patients with confirmed PR or CR per RECIST v1.1, assessed from the start of study treatment (defined as from first dose of pembrolizumab) for up to two years. ORR in the non-targeted, unirradiated lesion(s) as defined by CR or PR per iRECIST. Objective response will be assessed separately in all sites that are not irradiated.
Interventions
- DRUG Pembrolizumab
- RADIATION Radiotherapy
- DRUG Axatilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2026-06 |
| Est. Completion | 2033-07 |
| Phase | Phase 2 |
What is known before NCT07015853 opens enrollment
NCT07015853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07015853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07015853 about?
NCT07015853 is a clinical study titled "ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation". Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV...
What is the current status of trial NCT07015853?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2026-06. Estimated completion is 2033-07.
What interventions are being tested in trial NCT07015853?
The interventions under investigation include: Pembrolizumab (DRUG), Radiotherapy (RADIATION), Axatilimab (DRUG).
Who is sponsoring clinical trial NCT07015853?
This trial is sponsored by Stephen Shiao, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07015853's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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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