Puxitatug samrotecan compared with chemotherapy in B7-H4-selected endometrial cancer
Tests puxitatug samrotecan against chemotherapy in adults with advanced endometrial cancer that progressed.
Plain-language title generated from the registry record
Registry title: Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Key facts
- Where
- Alexandria, Aviano, Bari, Bologna, Catania, Florence, Milan, Monza, Naples, Padova, Parma, Pisa, Ponderano, Rome, Turin, and Vicenza, ItalySee the 21 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, ItalyTaking people
- Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Ospedaliera per l Emergenza CannizzaroCatania, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Humanitas Mirasole S.p.A.Milan, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Sanitaria Locale Della Provincia Di BiellaPonderano, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Unita Locale Socio Sanitaria N 8 BericaVicenza, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07044336EU 2024-518777-34-00
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
The main inclusion criteria include but are not limited to the following:; 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; The main exclusion criteria include but are not limited to the following:; Had uterine sarcomas or uterine neuroendocrine carcinoma; Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting; Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs ; Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent; History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening; Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses; Active or previously documented autoimmune or inflammatory disorders.