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)
Status: Recruiting
Location: See all (178) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
• Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression.
• Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
• A WHO/ECOG performance status of 0 or 1 at Screening.
• Has radiographically measurable disease by RECIST 1.1
Locations
United States
Florida
Research Site
RECRUITING
Jupiter
Research Site
NOT_YET_RECRUITING
Miami
Research Site
RECRUITING
Miami Beach
Research Site
NOT_YET_RECRUITING
Orlando
Hawaii
Research Site
NOT_YET_RECRUITING
Honolulu
Illinois
Research Site
NOT_YET_RECRUITING
Peoria
Indiana
Research Site
NOT_YET_RECRUITING
Indianapolis
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Research Site
NOT_YET_RECRUITING
Baltimore
Maine
Research Site
NOT_YET_RECRUITING
Scarborough
Michigan
Research Site
NOT_YET_RECRUITING
Ann Arbor
Research Site
NOT_YET_RECRUITING
Detroit
Minnesota
Research Site
NOT_YET_RECRUITING
Minneapolis
North Carolina
Research Site
NOT_YET_RECRUITING
Greenville
Research Site
NOT_YET_RECRUITING
Pinehurst
New Jersey
Research Site
NOT_YET_RECRUITING
Camden
Research Site
NOT_YET_RECRUITING
Paramus
New Mexico
Research Site
RECRUITING
Albuquerque
New York
Research Site
NOT_YET_RECRUITING
Brooklyn
Research Site
NOT_YET_RECRUITING
The Bronx
Research Site
NOT_YET_RECRUITING
White Plains
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Research Site
NOT_YET_RECRUITING
Cleveland
Research Site
NOT_YET_RECRUITING
Cleveland
Research Site
NOT_YET_RECRUITING
Dayton
Research Site
NOT_YET_RECRUITING
Hilliard
Research Site
NOT_YET_RECRUITING
Sylvania
Pennsylvania
Research Site
NOT_YET_RECRUITING
Hershey
Research Site
NOT_YET_RECRUITING
Pittsburgh
South Dakota
Research Site
NOT_YET_RECRUITING
Sioux Falls
Research Site
NOT_YET_RECRUITING
Sioux Falls
Texas
Research Site
NOT_YET_RECRUITING
Austin
Research Site
NOT_YET_RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Tyler
Virginia
Research Site
NOT_YET_RECRUITING
Fairfax
Research Site
NOT_YET_RECRUITING
Falls Church
Research Site
NOT_YET_RECRUITING
Norfolk
Research Site
NOT_YET_RECRUITING
Richmond
Research Site
NOT_YET_RECRUITING
Roanoke
Washington
Research Site
NOT_YET_RECRUITING
Seattle
Wisconsin
Research Site
NOT_YET_RECRUITING
Waukesha
West Virginia
Research Site
NOT_YET_RECRUITING
Morgantown
Other Locations
Argentina
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Capital Federal
Research Site
NOT_YET_RECRUITING
Cuidad Autónoma De Buenos Aire
Research Site
NOT_YET_RECRUITING
La Rioja
Research Site
NOT_YET_RECRUITING
Pergamino
Australia
Research Site
NOT_YET_RECRUITING
Melbourne
Research Site
NOT_YET_RECRUITING
Randwick
Research Site
NOT_YET_RECRUITING
Westmead
Austria
Research Site
NOT_YET_RECRUITING
Graz
Research Site
NOT_YET_RECRUITING
Vienna
Belgium
Research Site
NOT_YET_RECRUITING
Brussels
Research Site
NOT_YET_RECRUITING
Brussels
Research Site
NOT_YET_RECRUITING
Charleroi
Research Site
NOT_YET_RECRUITING
Edegem
Research Site
NOT_YET_RECRUITING
Ghent
Research Site
NOT_YET_RECRUITING
Leuven
Research Site
NOT_YET_RECRUITING
Liège
Research Site
NOT_YET_RECRUITING
Namur
Brazil
Research Site
NOT_YET_RECRUITING
Blumenau
Research Site
NOT_YET_RECRUITING
Natal
Research Site
NOT_YET_RECRUITING
Recife
Research Site
NOT_YET_RECRUITING
Rio De Janeiro
Research Site
NOT_YET_RECRUITING
São Caetano Do Sul
Research Site
NOT_YET_RECRUITING
São Paulo
Research Site
NOT_YET_RECRUITING
Sorocaba
Research Site
NOT_YET_RECRUITING
Taubaté
Canada
Research Site
NOT_YET_RECRUITING
Edmonton
Research Site
NOT_YET_RECRUITING
Montreal
Research Site
NOT_YET_RECRUITING
Montreal
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Changchun
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Chengdu
Research Site
NOT_YET_RECRUITING
Chongqing
Research Site
NOT_YET_RECRUITING
Dalian
Research Site
NOT_YET_RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Hangzhou
Research Site
NOT_YET_RECRUITING
Jinan
Research Site
NOT_YET_RECRUITING
Jinan
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shenyang
Research Site
NOT_YET_RECRUITING
Tianjin
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Xi'an
Finland
Research Site
NOT_YET_RECRUITING
Tampere
Research Site
NOT_YET_RECRUITING
Turku
France
Research Site
NOT_YET_RECRUITING
Avignon
Research Site
NOT_YET_RECRUITING
Besançon
Research Site
NOT_YET_RECRUITING
Bordeaux
Research Site
NOT_YET_RECRUITING
Chambray-lès-tours
Research Site
NOT_YET_RECRUITING
Grenoble
Research Site
NOT_YET_RECRUITING
Lille
Research Site
NOT_YET_RECRUITING
Limoges
Research Site
NOT_YET_RECRUITING
Lyon
Research Site
NOT_YET_RECRUITING
Nantes
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Plerin Sur Mer
Research Site
NOT_YET_RECRUITING
Toulouse
Georgia
Research Site
NOT_YET_RECRUITING
Batumi
Germany
Research Site
NOT_YET_RECRUITING
Chemnitz
Research Site
NOT_YET_RECRUITING
Freiburg Im Breisgau
Research Site
NOT_YET_RECRUITING
Heidelberg
Research Site
NOT_YET_RECRUITING
Münster
Greece
Research Site
NOT_YET_RECRUITING
Athens
Research Site
NOT_YET_RECRUITING
Athens
Research Site
NOT_YET_RECRUITING
Thessaloniki
Hungary
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Debrecen
Research Site
NOT_YET_RECRUITING
Győr
Israel
Research Site
NOT_YET_RECRUITING
Ashdod
Research Site
NOT_YET_RECRUITING
Haifa
Research Site
NOT_YET_RECRUITING
Holon
Research Site
NOT_YET_RECRUITING
Jerusalem
Research Site
NOT_YET_RECRUITING
Jerusalem
Research Site
NOT_YET_RECRUITING
Ramat Gan
Research Site
NOT_YET_RECRUITING
Safed
Research Site
NOT_YET_RECRUITING
Tel Aviv
Italy
Research Site
NOT_YET_RECRUITING
Bologna
Research Site
NOT_YET_RECRUITING
Catania
Research Site
NOT_YET_RECRUITING
Florence
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Monza
Research Site
NOT_YET_RECRUITING
Napoli
Research Site
NOT_YET_RECRUITING
Parma
Research Site
NOT_YET_RECRUITING
Pisa
Research Site
NOT_YET_RECRUITING
Ponderano
Research Site
NOT_YET_RECRUITING
Torino
Research Site
NOT_YET_RECRUITING
Vicenza
Japan
Research Site
NOT_YET_RECRUITING
Chūōku
Research Site
NOT_YET_RECRUITING
Hidaka-shi
Research Site
NOT_YET_RECRUITING
Isehara-shi
Research Site
NOT_YET_RECRUITING
Kōtoku
Research Site
NOT_YET_RECRUITING
Kurume-shi
Research Site
NOT_YET_RECRUITING
Matsuyama
Research Site
NOT_YET_RECRUITING
Minatoku
Research Site
NOT_YET_RECRUITING
Nagoya
Research Site
NOT_YET_RECRUITING
Niigata
Research Site
NOT_YET_RECRUITING
Okayama
Research Site
RECRUITING
Sapporo
Research Site
NOT_YET_RECRUITING
Sapporo
Research Site
NOT_YET_RECRUITING
Suita
Research Site
NOT_YET_RECRUITING
Sunto-gun
Research Site
NOT_YET_RECRUITING
Toon-shi
Research Site
NOT_YET_RECRUITING
Yokohama
Republic of Korea
Research Site
NOT_YET_RECRUITING
Goyang-si
Research Site
NOT_YET_RECRUITING
Gwangjin-gu
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Songpa-gu
Slovenia
Research Site
NOT_YET_RECRUITING
Ljubljana
Research Site
NOT_YET_RECRUITING
Maribor
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Córdoba
Research Site
NOT_YET_RECRUITING
El Palmar (murcia)
Research Site
NOT_YET_RECRUITING
Hospitalet Del Llobregat
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Santiago De Compostela
Research Site
NOT_YET_RECRUITING
Seville
Research Site
NOT_YET_RECRUITING
Seville
Taiwan
Research Site
NOT_YET_RECRUITING
New Taipei City
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Tainan City
Research Site
NOT_YET_RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taipei
United Kingdom
Research Site
NOT_YET_RECRUITING
London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-04-03
Participants
Target number of participants: 700
Treatments
Experimental: Puxitatug Samrotecan
P-Sam IV (intravenous) Q3W .
Active_comparator: Chemotherapy
Physician's choice of chemotherapy~Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca