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
- Belém, Belo Horizonte, Bento Gonçalves, Blumenau, Curitiba, Florianópolis, Joinville, Natal, Porto Alegre, Recife, Ribeirão Preto, Rio de Janeiro, Salvador, São Caetano do Sul, São Paulo, Sorocaba, Taubaté, and Teresina, BrazilSee the 18 sites
- Phase
- Phase 3
Where in Brazil
- BelémBelém, BrazilNot yet recruiting
- Belo HorizonteBelo Horizonte, BrazilTaking people
- Bento GonçalvesBento Gonçalves, BrazilNot yet recruiting
- BlumenauBlumenau, BrazilTaking people
- CuritibaCuritiba, BrazilNo longer taking part
- FlorianópolisFlorianópolis, BrazilNot yet recruiting
- JoinvilleJoinville, BrazilNot yet recruiting
- NatalNatal, BrazilTaking people
- Porto AlegrePorto Alegre, BrazilTaking people
- RecifeRecife, BrazilNot yet recruiting
- Ribeirão PretoRibeirão Preto, BrazilNot yet recruiting
- Rio de JaneiroRio de Janeiro, BrazilNot yet recruiting
- SalvadorSalvador, BrazilTaking people
- São Caetano do SulSão Caetano do Sul, BrazilTaking people
- São PauloSão Paulo, BrazilNot yet recruiting
- SorocabaSorocaba, BrazilTaking people
- TaubatéTaubaté, BrazilTaking people
- TeresinaTeresina, BrazilNot yet recruiting
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.