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Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Sponsor: AstraZeneca
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.
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2025-08-01
Completion Date
2029-07-17
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Locations (320)
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Tucson, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Washington D.C., District of Columbia, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Urbana, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Camden, New Jersey, United States
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Paramus, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Greenville, North Carolina, United States
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Pinehurst, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Hilliard, Ohio, United States
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Sylvania, Ohio, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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York, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Fairfax, Virginia, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Waukesha, Wisconsin, United States
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Capital Federal, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Cuidad Autónoma de Buenos Aire, Argentina
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La Rioja, Argentina
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Pergamino, Argentina
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Viedma, Argentina
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Malvern, Australia
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Melbourne, Australia
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Randwick, Australia
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St Leonards, Australia
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Subiaco, Australia
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Westmead, Australia
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Graz, Austria
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Innsbruck, Austria
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Vienna, Austria
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Brussels, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Liège, Belgium
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Namur, Belgium
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Belém, Brazil
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Belo Horizonte, Brazil
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Bento Gonçalves, Brazil
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Blumenau, Brazil