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Puxitatug Samrotecan for Endometrial Cancer

This study is testing a drug called Puxitatug Samrotecan against standard chemotherapy (Doxorubicin or Paclitaxel) for advanced or metastatic endometrial cancer. You may be able to join if you are a woman aged 18 or older with endometrial cancer that has come back or spread, and has already been treated with platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapies. The study is looking to see if Puxitatug Samrotecan helps people live longer without their cancer getting worse, or live longer overall, compared to chemotherapy. The study is currently recruiting for 800 participants.

Study design
This is a Phase III, randomized, open-label study involving approximately 700 participants. Participants will be randomly assigned to receive either Puxitatug Samrotecan or chemotherapy.
What's involved
During treatment, participants will receive Puxitatug Samrotecan intravenously (IV) on Day 1 every three weeks, or Doxorubicin IV on Day 1 every three weeks, or Paclitaxel IV on Days 1, 8, and 15 in a 28-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for approximately 3 years to measure how long they live without their cancer getting worse and their overall survival.

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NCT07044336

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~800 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Puxitatug SamrotecanDoxorubicinPaclitaxel

At a glance

Recruiting sites
212 of 320 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) for Arm A vs Arm B
Measured over Approximately 3 years
+1 more outcome measured

Conditions

Endometrial Cancer
Malignant Solid Tumour

Explore related trials

Endometrial Carcinoma

Where it's being run

320 sites across 55 states
China33
Brazil28
Japan21
Italy20
France18
Germany17
Spain14
Israel10

Study leadership

  • Brian Slomovitz, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Stephanie Gaillard, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)
  • Nicole Concin, Prof. · PRINCIPAL_INVESTIGATOR · Head of the Division of General Gynecology and Gynecologic Oncology at the Department of Obstetrics and Gynecology of MedUni Vienna and University

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Progression Free Survival (PFS) for Arm A vs Arm BApproximately 3 years

    PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.

  • Overall survival (OS) for Arm A vs Arm BApproximately 3 years

    OS is defined as the time from randomization until the date of death due to any cause.