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

RecruitingPhase 3

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)

Who can join

Ages 18 and older · Women

Full eligibility 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

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 800 · Started: Aug 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07044336

Locations in the U.S.

ArizonaResearch Site, Tucson (Not yet recruiting)
CaliforniaResearch Site, La Jolla
Research Site, Orange
District of ColumbiaResearch Site, Washington D.C. (Not yet recruiting)
FloridaResearch Site, Jupiter
Research Site, Miami (Not yet recruiting)
Research Site, Miami
Research Site, Miami Beach
Research Site, New Port Richey
Research Site, Orlando
Research Site, Tampa (Not yet recruiting)
Research Site, West Palm Beach
HawaiiResearch Site, Honolulu (Not yet recruiting)
IllinoisResearch Site, Chicago
Research Site, Peoria
Research Site, Urbana
IndianaResearch Site, Fort Wayne
Research Site, Indianapolis
MaineResearch Site, Scarborough
MarylandResearch Site, Baltimore (Not yet recruiting)
Research Site, Baltimore
Research Site, Silver Spring
MichiganResearch Site, Ann Arbor (Not yet recruiting)
Research Site, Ann Arbor
MinnesotaResearch Site, Minneapolis
New JerseyResearch Site, Camden (Not yet recruiting)
Research Site, Paramus
New MexicoResearch Site, Albuquerque
New YorkResearch Site, Brooklyn (Not yet recruiting)
Research Site, Stony Brook
Research Site, The Bronx
Research Site, White Plains
North CarolinaResearch Site, Greenville
Research Site, Pinehurst
OhioResearch Site, Cincinnati
Research Site, Cleveland
Research Site, Cleveland
Research Site, Columbus
Research Site, Dayton
Research Site, Hilliard
Research Site, Sylvania
OregonResearch Site, Eugene
Research Site, Portland (Not yet recruiting)
PennsylvaniaResearch Site, Bethlehem
Research Site, Hershey
Research Site, Lancaster (Not yet recruiting)
Research Site, Philadelphia (Not yet recruiting)
Research Site, Pittsburgh (Not yet recruiting)
Research Site, Pittsburgh (Not yet recruiting)
Research Site, Willow Grove
Research Site, York (Not yet recruiting)
South DakotaResearch Site, Sioux Falls (Not yet recruiting)
Research Site, Sioux Falls
TennesseeResearch Site, Knoxville
Research Site, Nashville (Not yet recruiting)
TexasResearch Site, Austin
Research Site, Houston (Not yet recruiting)
Research Site, Tyler
VirginiaResearch Site, Fairfax
Research Site, Falls Church
Research Site, Norfolk
Research Site, Richmond
Research Site, Roanoke
WashingtonResearch Site, Kennewick (Not yet recruiting)
Research Site, Seattle (Not yet recruiting)
West VirginiaResearch Site, Morgantown
WisconsinResearch Site, Waukesha

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.