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

Recruiting now · Phase 3

Conditions studied: Endometrial Cancer, Malignant Solid Tumour

In brief

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.

Key facts

Study ID

NCT07044336

Run by

AstraZeneca

People needed

800

Starts

2025-08-01

Expected to finish

2029-07-17

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Research Site — Paramus, New Jersey, United States (enrolling)
• Research Site — Greenville, North Carolina, United States (enrolling)
• Research Site — Orange, California, United States (enrolling)
• Research Site — Minneapolis, Minnesota, United States (enrolling)
• Research Site — Stony Brook, New York, United States (enrolling)
• Research Site — White Plains, New York, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami Beach, Florida, United States (enrolling)
• Research Site — La Jolla, California, United States (enrolling)
• Research Site — Orlando, Florida, United States (enrolling)
• Research Site — Albuquerque, New Mexico, United States (enrolling)
• Research Site — West Palm Beach, Florida, United States (enrolling)
• Research Site — The Bronx, New York, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Peoria, Illinois, United States (enrolling)
• Research Site — Urbana, Illinois, United States (enrolling)
• Research Site — Fort Wayne, Indiana, United States (enrolling)
• Research Site — Indianapolis, Indiana, United States (enrolling)
• Research Site — Scarborough, Maine, United States (enrolling)
• Research Site — New Port Richey, Florida, United States (enrolling)
• Research Site — Baltimore, Maryland, United States (enrolling)
• Research Site — Silver Spring, Maryland, United States (enrolling)
• Research Site — Jupiter, Florida, United States (enrolling)
• Research Site — Ann Arbor, Michigan, United States (enrolling)
• Research Site — Pinehurst, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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