RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Jupiter

Research Site, Jupiter, Florida, United States, 33458

Miami

Research Site, Miami, Florida, United States, 33176

Miami Beach

Research Site, Miami Beach, Florida, United States, 33140

Orlando

Research Site, Orlando, Florida, United States, 32806

Honolulu

Research Site, Honolulu, Hawaii, United States, 96826

Peoria

Research Site, Peoria, Illinois, United States, 61637

Indianapolis

Research Site, Indianapolis, Indiana, United States, 46260

Scarborough

Research Site, Scarborough, Maine, United States, 04074

Baltimore

Research Site, Baltimore, Maryland, United States, 21201

Baltimore

Research Site, Baltimore, Maryland, United States, 21231

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    FEMALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    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

    2028-04-03