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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT07044336

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Puxitatug Samrotecan (drug), Doxorubicin (drug), Paclitaxel (drug)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Puxitatug Samrotecan — drug: 2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion · Doxorubicin — drug: 60 mg/m2 on Day 1 Q3W Route of administration: IV · Paclitaxel — drug: 80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by AstraZeneca and called Bluestar-Endometrial01, is for people with endometrial cancer (including a type called carcinosarcoma) that has come back or spread. It compares a new medicine called puxitatug samrotecan (also known as AZD8205), given on its own, with chemotherapy. The study focuses on cancers selected using a marker in the body called B7-H4.

Who can take part

  • Diagnosis of endometrial carcinoma or carcinosarcoma confirmed by looking at tissue under a microscope
  • Cancer that has come back (recurred) or spread to other parts of the body, shown by scans or other evidence
  • Have already had platinum-based chemotherapy and treatment with a type of immunotherapy (anti-PD-1 or anti-PD-L1 therapy), either separately or together
  • Able to carry out light activity (WHO/ECOG performance status of 0 or 1), measured at screening
  • Cancer that can be measured on scans using standard guidelines (RECIST 1.1)

Who may not be able to

  • Have uterine sarcoma or uterine neuroendocrine carcinoma
  • Cancer came back more than 12 months after finishing platinum-based therapy given to try to cure the cancer, with no further platinum-based treatment since
  • Have had any previous treatment (approved or experimental) containing a 'TOP1i' medicine, including antibody-drug conjugates (ADCs)
  • Have had puxitatug samrotecan or any other treatment targeting B7-H4
  • Have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) needing steroids, have it now, or where it cannot be ruled out on scans at screening
  • Have serious lung problems from another current lung illness
  • Have an active autoimmune or inflammatory condition, or have had one in the past

What taking part involves

  • • You would be given either puxitatug samrotecan on its own, or chemotherapy (which one you get is not stated — ask the trial team)

Time commitment: Not stated — ask the trial team (how many visits, how long the study lasts, and what taking part involves are not given in the data above)

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
800
Started
2025-08-01
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for endometrial cancer
  • • Phase3 - 800 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with endometrial cancer
  • • Female only

Where?

  • • Bebington - Research Site
  • • Canterbury - Research Site
  • • Derby - Research Site
  • • London - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC 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 advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be approximately 700 eligible participants. During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15 in 28-day cycle (Arm B). This study aims to see if Puxi-Sam 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 participants' quality of life.

Endometrial CancerMalignant Solid Tumour

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

PD-L1

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓confirmed by a biopsy diagnosis of endometrial carcinoma or carcinosarcoma.
  • ✓Recurrent/that has spread EC ie, with radiological or objective evidence of recurrence or progression.
  • ✓Has received prior platinum-based drug treatment and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell...
  • ✓A WHO/Fit enough for normal activity (ECOG 0) or 1 at Screening.
See the full 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 Is This Study? (9 UK sites)

Research Site

Bebington CH63 4JY, United Kingdom

Recruiting

Research Site

Canterbury CT1 3NG, United Kingdom

Recruiting

Research Site

Derby DE22 3NE, United Kingdom

WITHDRAWN

Research Site

London E1 1BB, United Kingdom

Recruiting

Research Site

London SE1 7EH, United Kingdom

NOT_YET_RECRUITING

Research Site

London W2 1NY, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Northwood HA6 2RN, United Kingdom

NOT_YET_RECRUITING

Research Site

Truro TR1 3LJ, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07