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

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NCT07044336 · readout in 422 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
800estimated
Sites
320
Countries
Argentina, Australia, Austria +25

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-08-01actualWhen the study began enrolling
Primary completion2027-10-15estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-07-17estimatedThe whole study's end, after follow-up
First posted2025-06-30actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Endometrial Cancer
  • Malignant Solid Tumour

Interventions

  • Drug: Puxitatug Samrotecan — also filed as Puxi-Sam
  • Drug: Doxorubicin — also filed as ADRIAMYCIN®
  • Drug: Paclitaxel — also filed as TAXOL®

Primary outcomes

what the primary-completion date above is the date OF
Progression Free Survival (PFS) for Arm A vs Arm B
measured Approximately 3 years
Overall survival (OS) for Arm A vs Arm B
measured Approximately 3 years

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