Clinical trialNCT07044336RecruitingPhase 3Interventional

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

SponsorAstraZenecaEnrollment800Endometrial CancerMalignant Solid Tumour

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Brian Slomovitz, MD
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗
Nicole Concin, Prof.
Head of the Division of General Gynecology and Gynecologic Oncology at the Department of Obstetrics and Gynecology of MedUni Vienna and University
Principal Investigator
clinicaltrials.gov ↗
Stephanie Gaillard, MD, PhD
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

320 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Research Site
Capital Federal, Argentina
Recruiting
Research Site
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Research Site
Ciudad de Buenos Aires, Argentina
Recruiting
Research Site
Cuidad Autónoma de Buenos Aire, Argentina
Recruiting
Research Site
Córdoba, Argentina
Not, yet, recruiting
Research Site
Córdoba, Argentina
Recruiting
Research Site
La Rioja, Argentina
Recruiting
Research Site
Pergamino, Argentina
Recruiting
Research Site
Viedma, Argentina
Recruiting

Australia

Research Site
Malvern, Australia
Recruiting
Research Site
Melbourne, Australia
Recruiting
Research Site
Randwick, Australia
Recruiting
Research Site
St Leonards, Australia
Recruiting
Research Site
Subiaco, Australia
Recruiting
Research Site
Westmead, Australia
Recruiting

Austria

Research Site
Graz, Austria
Recruiting
Research Site
Innsbruck, Austria
Recruiting
Research Site
Vienna, Austria
Recruiting

Belgium

Research Site
Brussels, Belgium
Recruiting
Research Site
Brussels, Belgium
Recruiting
Research Site
Charleroi, Belgium
Recruiting
Research Site
Edegem, Belgium
Recruiting
Research Site
Ghent, Belgium
Recruiting
Research Site
Leuven, Belgium
Recruiting
Research Site
Liège, Belgium
Not, yet, recruiting
Research Site
Liège, Belgium
Recruiting
Research Site
Namur, Belgium
Recruiting

Brazil

Research Site
Belo Horizonte, Brazil
Recruiting
Research Site
Belém, Brazil
Not, yet, recruiting
Research Site
Bento Gonçalves, Brazil
Not, yet, recruiting
Research Site
Blumenau, Brazil
Recruiting
Research Site
Curitiba, Brazil
Withdrawn
Research Site
Curitiba, Brazil
Recruiting
Research Site
Florianópolis, Brazil
Not, yet, recruiting
Research Site
Joinville, Brazil
Not, yet, recruiting
Research Site
Natal, Brazil
Recruiting
Research Site
Porto Alegre, Brazil
Recruiting
Research Site
Porto Alegre, Brazil
Not, yet, recruiting
Research Site
Porto Alegre, Brazil
Recruiting
Research Site
Recife, Brazil
Not, yet, recruiting

280 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Doxorubicin →Paclitaxel →Puxitatug Samrotecan

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Aug 2025
Primary completion: 15 Oct 2027
Completion: 17 Jul 2029
Last update posted: 29 Jul 2026
Registered enrollment: 800
Registry id: NCT07044336

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.