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
- Badalona, Barcelona, Córdoba, L'Hospitalet de Llobregat, Madrid, Málaga, Murcia, Oviedo, Santiago de Compostela, Sevilla, and Valencia, SpainSee the 14 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with advanced or spread endometrial cancer whose tumour has the B7-H4 marker and whose disease got worse after platinum chemotherapy and anti-PD-1/anti-PD-L1 treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Endometrial carcinoma or carcinosarcoma that has come back or spread, with signs of recurrence or progression on scans, and disease that can be measured by RECIST 1.1
- Earlier treatment
- Must have had platinum-based chemotherapy and anti-PD-1/anti-PD-L1 treatment, separately or together
- Biomarker or test result
- B7-H4-selected tumour
Main reasons for not taking part
- Uterine sarcoma or uterine neuroendocrine carcinoma
- Cancer came back more than 12 months after platinum treatment meant to remove all of the disease, with no further platinum treatment since
- Earlier treatment with a TOP1i drug, including antibody-drug conjugates
- Earlier treatment with puxitatug samrotecan or another B7-H4 targeting drug
- Lung inflammation (ILD/pneumonitis) that needed steroids, or current lung inflammation
Read by machine on 9 November 2026.
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Vall d'Hebron Institute of OncologyBarcelona, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- MD Anderson Cancer CenterMadrid, SpainTaking people
- Hospital Universitario Regional de MálagaMálaga, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Hospital Universitario Virgen De ValmeSevilla, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking 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.