Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
AstraZeneca
700 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
60 mg/m2 on Day 1 Q3W Route of administration: IV
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Locations(307)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07044336