Taking people in FrancePhase 3
Puxitatug samrotecan compared with chemotherapy in B7-H4-selected endometrial cancer
Tests puxitatug samrotecan against chemotherapy in adults with advanced endometrial cancer that progressed.
Key facts
- Who runs it
- AstraZeneca
- Where
- Avignon Cedex 9, Besancon Cedex, Bordeaux, Chambray-lès-Tours, Cholet, Créteil, Grenoble, Lille, Limoges, Lyon, Nantes Cedex 2, Nimes Cedex 9, Paris, Plerin, and Rennes Cedex, FranceSee the 18 sitesAlso in 27 other countries, 263 sites
- Trial code
- Registry title
- Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 800 people, planned
- Started
- 1 Aug 2025
- Expected to end
- 17 Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Puxitatug Samrotecan
- Doxorubicin
- Paclitaxel
- Record updated
- 29 July 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 13 criteriaShow less
Other criteria
- 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
Where in France
Also in 27 other countries, 263 sites
- Sainte Catherine Institut Du Cancer Avignon-ProvenceAvignon Cedex 9, FranceTaking people
- CHU BesanconBesancon Cedex, FranceTaking people
- Institut BergonieBordeaux, FranceTaking people
- Pole Sante Leonard De VinciChambray-lès-Tours, FranceTaking people
- Centre Hospitalier de CholetCholet, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Union Mut Gestion Groupe Hosp Mutualiste De GrenobleGrenoble, FranceTaking people
- Centre Oscar LambretLille, FranceTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Hôpital Privé Jean MermozLyon, FranceTaking people
- L'Hopital Prive Du ConfluentNantes Cedex 2, FranceTaking people
- Oncoradio Centre OncogardNimes Cedex 9, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Fondation Hôpital Saint-JosephParis, FranceTaking people
- Groupe Hospitalier Diaconesses Croix Saint-SimonParis, FranceTaking people
- CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'OncologiePlerin, FranceTaking people
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranceTaking people
About the trial
What the trial wants to find out
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 2 groups in the trial
- Puxitatug SamrotecanTreatment being tested
Puxi-Sam IV (intravenous) Q3W .
- ChemotherapyExisting treatment, for comparison
Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
Treatment: Doxorubicin and Paclitaxel
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Puxitatug samrotecan compared with chemotherapy in B7-H4-selected endometrial cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 July 2026