Comparing Puxitatug Samrotecan with Doxorubicin for endometrial cancer
Official title: Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
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)
- Phase 3
- 2 groups
- Sites in Edmonton, Winnipeg and 3 more cities
- Recruiting
Interventions
- Medication
Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
- Medication
Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
- Medication
Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Canadian Sites (6)
6 listed, none recruiting
- Not yet recruiting
Research Site
Edmonton, Alberta
- Not yet recruiting
Research Site
Winnipeg, Manitoba
- Not yet recruiting
Research Site
Hamilton, Ontario
- Not yet recruiting
Research Site
Kingston, Ontario
- Not yet recruiting
Research Site
Montreal, Quebec
- Not yet recruiting
Research Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 radiographically measurable disease by RECIST 1.1
- +The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- +Active or previously documented autoimmune or inflammatory disorders
- +A WHO/ECOG performance status of 0 or 1 at Screening.
- +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.
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- −Active or previously documented autoimmune or inflammatory disorders
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Puxitatug Samrotecan.
Registry label: A: Puxitatug Samrotecan
Group B, the comparison group, receives one or more of: Doxorubicin and Paclitaxel.
Registry label: B: Chemotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 800 people.
The study is currently expected to finish around July 2029.
The main measurement is taken over: Approximately 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) for ArmArmOne of the groups in a study, each receiving something different.Read more → A vs Arm B — measured over Approximately 3 years.
Overall survival (OS) for Arm A vs Arm B — measured over Approximately 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07044336 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Puxitatug SamrotecanDrug
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DoxorubicinDrug
60 mg/m2 on Day 1 Q3W Route of administration: IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 3 years.
The study as a whole is currently expected to finish around 2029-07-17.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (10)
Research Site
Ann Arbor, Michigan, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Brooklyn, New York, United States
Research Site
Stony Brook, New York, United States
Research Site
The Bronx, New York, United States
Research Site
White Plains, New York, United States
Research Site
Kennewick, Washington, United States
Research Site
Seattle, Washington, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.