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 (299) 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
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Tucson
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La Jolla
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Chicago
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Pinehurst
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Camden
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Paramus
New Mexico
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Albuquerque
New York
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Cleveland
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Norfolk
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Argentina
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Capital Federal
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Ciudad De Buenos Aires
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Córdoba
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Cuidad Autónoma De Buenos Aire
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La Rioja
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Australia
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Avignon
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Batumi
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Tbilisi
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Germany
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Amberg
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Chemnitz
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Dresden
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Frankfurt Am Main
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Münster
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Regensburg
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Ulm
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Witten
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Athens
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Athens
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Thessaloniki
Hungary
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Budapest
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Debrecen
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Israel
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Ashdod
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Haifa
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Holon
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Catania
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Florence
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Haifa
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Nagoya
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Sendai
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Suita
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Toon-shi
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Tsu
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Yokohama
Lithuania
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Kaunas
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Vilnius
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Vilnius
Netherlands
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Amsterdam
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Maastricht
Poland
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Lodz
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Siedlce
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Goyang-si
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Gwangjin-gu
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Seoul
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Seoul
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Songpa-gu
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Suwon
Singapore
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Singapore
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Singapore
Slovenia
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Ljubljana
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Maribor
Spain
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Badalona
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Barcelona
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Barcelona
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Córdoba
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El Palmar (murcia)
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Hospitalet Del Llobregat
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Madrid
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Madrid
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Málaga
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Oviedo
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Seville
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Seville
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Valencia
Taiwan
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New Taipei City
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Taichung
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Tainan
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Taipei
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Taipei
United Kingdom
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Bebington
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Canterbury
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Derby
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London
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London
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Manchester
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Northwood
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Truro
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: 2029-07-17
Participants
Target number of participants: 700
Treatments
Experimental: Puxitatug Samrotecan
Puxi-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