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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07044336
Registration number
NCT07044336
Ethics application status
Date submitted
23/06/2025
Date registered
30/06/2025
Date last updated
28/08/2025
Titles & IDs
Public title
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
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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 (Bluestar-Endometrial01)
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Secondary ID [1]
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D6900C00003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer
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0
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Malignant Solid Tumour
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Puxitatug Samrotecan
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel
Experimental: Puxitatug Samrotecan - P-Sam IV (intravenous) Q3W .
Active comparator: Chemotherapy - Physician's choice of chemotherapy
Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
Treatment: Drugs: Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Treatment: Drugs: Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
Treatment: Drugs: Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycles Route of Administration: IV
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) for Arm A vs Arm B
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Assessment method [1]
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PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
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Timepoint [1]
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Approximately 3 years
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Primary outcome [2]
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Overall survival (OS) for Arm A vs Arm B
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Assessment method [2]
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OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [1]
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Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
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Assessment method [1]
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ORR is defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessments, per RECIST 1.1.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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Assessment of Duration of response (DoR) for Arm A vs Arm B
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Assessment method [2]
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DoR will be defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [3]
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Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
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Assessment method [3]
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PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death.
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Timepoint [3]
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Approximately 3 years
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Secondary outcome [4]
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Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
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Assessment method [4]
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TFST is defined as the time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of the randomized treatment, or death due to any cause.
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Timepoint [4]
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Approximately 3 years
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Secondary outcome [5]
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Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B
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Assessment method [5]
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TSST is defined as the time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death due to any cause.
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Timepoint [5]
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Approximately 3 years
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Secondary outcome [6]
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Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B
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Assessment method [6]
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TDT is defined as the time from randomization until discontinuation of treatment for any reason, including disease progression, toxicity, and death.
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Timepoint [6]
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Approximately 3 years
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Secondary outcome [7]
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Worsening in endometrial symptoms for Arm A vs Arm B
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Assessment method [7]
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Time to worsening is defined as time from date of randomization to the date of worsening while on treatment for endometrial symptoms, physical functioning, and health-related quality of life based on select items from the EORTC IL389.
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Timepoint [7]
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Approximately 3 years
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Eligibility
Key inclusion 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 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/04/2028
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne
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Research Site - Randwick
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Research Site - Westmead
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3000 - Melbourne
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment outside Australia
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Ramat Gan
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Tel Aviv
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Torino
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Tainan City
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07044336
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Brian Slomovitz, MD
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Address
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Icahn School of Medicine at Mount Sinai
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Query!
Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07044336
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