drugset / Trial / NCT07015853
ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
Phase 2
Not yet recruiting
34 enrolled
Stephen Shiao
Incyte Corporation · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-06
- Primary completion
- 2033-07
- Completion
- 2033-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axatilimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |