RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2025-08-01
Study Completion:2028-04-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07044336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Brian Slomovitz, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Stephanie Gaillard, MD, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)
Christian Marth, MD, PhD
PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck

Study Locations (Sites)

Research Site
Jupiter, Florida, 33458
United States
Research Site
Miami, Florida, 33176
United States
Research Site
Miami Beach, Florida, 33140
United States
Research Site
Orlando, Florida, 32806
United States
Research Site
Honolulu, Hawaii, 96826
United States
Research Site
Peoria, Illinois, 61637
United States
Research Site
Indianapolis, Indiana, 46260
United States
Research Site
Scarborough, Maine, 04074
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Baltimore, Maryland, 21231
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
Minneapolis, Minnesota, 55404
United States
Research Site
Camden, New Jersey, 08103
United States
Research Site
Paramus, New Jersey, 07652
United States
Research Site
Albuquerque, New Mexico, 87109
United States
Research Site
Brooklyn, New York, 11220
United States
Research Site
The Bronx, New York, 10461
United States
Research Site
White Plains, New York, 10601
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Pinehurst, North Carolina, 28374
United States
Research Site
Cincinnati, Ohio, 45220
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Cleveland, Ohio, 44109
United States
Research Site
Dayton, Ohio, 45459
United States
Research Site
Hilliard, Ohio, 43026
United States
Research Site
Sylvania, Ohio, 43560
United States
Research Site
Hershey, Pennsylvania, 17033
United States
Research Site
Pittsburgh, Pennsylvania, 15224
United States
Research Site
Sioux Falls, South Dakota, 57104
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Austin, Texas, 78758
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Tyler, Texas, 75702
United States
Research Site
Falls Church, Virginia, 22042
United States
Research Site
Richmond, Virginia, 23298
United States
Research Site
Roanoke, Virginia, 24016
United States
Research Site
Seattle, Washington, 98104
United States
Research Site
Morgantown, West Virginia, 26505
United States
Research Site
Waukesha, Wisconsin, 53188
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Brian Slomovitz, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Stephanie Gaillard, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)
  • Christian Marth, MD, PhD, PRINCIPAL_INVESTIGATOR, Medical University of Innsbruck

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2028-04-03

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2028-04-03

Terms related to this study

Keywords Provided by Researchers

  • Bluestar-Endometrial01
  • AZD8205
  • Puxitatug Samrotecan
  • P-Sam
  • Platinum-based chemotherapy
  • B7-H4
  • advanced/metastatic
  • Endometrial Cancer
  • Anti-PD-1
  • Anti-PD-L1
  • antibody-drug conjugate
  • Topoisomerase 1 Inhibitors
  • uterine neoplasm
  • female urogenital neoplasm

Additional Relevant MeSH Terms

  • Endometrial Cancer
  • Malignant Solid Tumour