drugset / Trial / NCT07044336
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2027-10-15
- Completion
- 2029-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Puxitatug Samrotecan | Unknown | 2.4 mg/kg | Intravenous |