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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 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.

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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.

Conditions Studied

Endometrial Cancer Malignant Solid Tumour

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

FieldValue
Enrollment Target 700 participants
Start Date 2025-08-01
Est. Completion 2029-07-17
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07044336

The ClinicalTrials.gov registry entry for NCT07044336 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 520-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (35% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.