Clinical Trial

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

Recruiting Phase 3
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Summary
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
Protocol Amendment History 6 changes
notable Trial sites expanded: 317 -> 320 locations 2026-07-30
notable Enrollment increased: 700 -> 800 participants 2026-06-11
notable Trial sites expanded: 314 -> 317 locations 2026-06-11
notable Primary completion moved earlier: 2028-01-20 -> 2027-10-15 2026-06-11
notable Trial sites expanded: 307 -> 314 locations 2026-05-21
notable Trial sites expanded: 294 -> 307 locations 2026-04-14
Trial Details
NCT Number NCT07044336
Lead Sponsor AstraZeneca
Conditions Endometrial Cancer, Malignant Solid Tumour
Enrollment 800 participants
Start Date 2025-08-01
Primary Completion 2027-10-15 (estimated)
Study Completion 2029-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-29