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

NCT07044336 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-05-20

No results posted yet for this 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

Interventions

DRUG

Puxitatug Samrotecan

2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion

DRUG

Doxorubicin

60 mg/m2 on Day 1 Q3W Route of administration: IV

DRUG

Paclitaxel

80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV

Sponsors & Collaborators

Principal Investigators

  • Brian Slomovitz, MD · Icahn School of Medicine at Mount Sinai

  • Stephanie Gaillard, MD, PhD · Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)

  • Nicole Concin, Prof. · Head of the Division of General Gynecology and Gynecologic Oncology at the Department of Obstetrics and Gynecology of MedUni Vienna and University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2028-01-20
Completion
2029-07-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Netherlands
  • Poland
  • Singapore
  • Slovenia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044336 on ClinicalTrials.gov