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RecruitingLast updated: 25 February 2026

Bluestar-Endometrial01: This trial is for people with advanced or metastatic endometrial cancer who have had prior treatment to compare the effectiveness of a targeted treatment with chemotherapyPuxitatug 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

Bluestar-Endometrial01

Clinical summary

Summary

Participants in this trial will be randomly allocated (by chance) to one of two treatment arms.

In Arm A, participants will receive a targeted drug called puxitatug samrotecan (also called AZD8205) intravenously (IV) every three weeks. 

In Arm B, participants will receive physician's choice of standard of care chemotherapy. This will either be doxorubicin IV every 3 weeks, or paxlitazel IV on days 1, 8 and 15 of a 28-day cycle.

The study aims to see if puxitatug samrotecan allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participant's quality of life.

Who can participate

The target population of interest in this study is people with B7-H4-selected advanced or metastatic endometrial cancer who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination, and should have received no more than 2 prior lines of therapy in the advanced or metastatic setting.

Conditions

This trial is treating people with endometrial cancer that is recurrent or metastatic

Eligibility

Inclusion

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

Exclusion

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 AZD8205 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific 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

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