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NCT07044336 · ClinicalTrials.gov registry record · Phase 3
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
A Phase 3 study of Endometrial Cancer and Malignant Solid Tumour, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT07044336: Recruiting Phase 3 study of Endometrial Cancer and Malignant Solid Tumour, sponsored by AstraZeneca.
NCT07044336 is a Phase 3 study of Endometrial Cancer and Malignant Solid Tumour that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 700 participants, above the 520-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07044336, a Phase 3 study of Endometrial Cancer and Malignant Solid Tumour, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Puxitatug Samrotecan
Study Locations (20)
Florida
- Research Site - Jupiter
- Research Site - Miami
- Research Site - Miami
- Research Site - Miami Beach
- Research Site - Orlando
- Research Site - West Palm Beach
California
- Research Site - La Jolla
- Research Site - Los Angeles
- Research Site - Orange
Illinois
- Research Site - Chicago
- Research Site - Peoria
- Research Site - Urbana
Maryland
- Research Site - Baltimore
- Research Site - Baltimore
- Research Site - Silver Spring
Indiana
- Research Site - Fort Wayne
- Research Site - Indianapolis
Arizona
- Research Site - Tucson
Hawaii
- Research Site - Honolulu
Maine
- Research Site - Scarborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2029-07-17 |
| Phase | Phase 3 |
What NCT07044336 shows while recruiting
NCT07044336 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 520-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (35% higher).
The record links to 2 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 3 interventions - of which Doxorubicin is the first listed.
NCT07044336 names 20 study sites across 8 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT07044336 about?
NCT07044336 is a clinical study titled "Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)". 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 plat...
What is the current status of trial NCT07044336?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2025-08-01. Estimated completion is 2029-07-17.
What conditions does trial NCT07044336 study?
This clinical trial studies the following conditions: Endometrial Cancer, Malignant Solid Tumour.
What interventions are being tested in trial NCT07044336?
The interventions under investigation include: Doxorubicin (DRUG), Paclitaxel (DRUG), Puxitatug Samrotecan (DRUG).
Who is sponsoring clinical trial NCT07044336?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07044336 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07044336's enrollment target sits among peer trials
700 22nd of 181 higher than 160 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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