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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (9 UK sites)
Research Site
Bebington CH63 4JY, United Kingdom
Research Site
Canterbury CT1 3NG, United Kingdom
Research Site
Derby DE22 3NE, United Kingdom
Research Site
London E1 1BB, United Kingdom
Research Site
London SE1 7EH, United Kingdom
Research Site
London W2 1NY, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Northwood HA6 2RN, United Kingdom
Research Site
Truro TR1 3LJ, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
