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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07044336.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Approved
Name Not Available
The target population of interest in this study is participants with B7-H4-selected
advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and
anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have
received no more than 2 prior lines of therapy in advanced/metastatic setting.
Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice
of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be
approximately 700 eligible participants.
During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or
either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15
in 28-day cycle (Arm B).
This study aims to see if Puxi-Sam allows participants to live longer without their
endometrial cancer getting worse, or simply to live longer, compared to participants
receiving standard of care chemotherapy. This study is also looking to see how the
treatment and the endometrial cancer affects participants' quality of life.
Lead OrganizationAstraZeneca Pharmaceuticals LP
Principal InvestigatorBrian M Slomovitz