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.
Additional locations may be listed on ClinicalTrials.gov for NCT07044336.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 AZD8205 (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 AZD8205 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 cycles (Arm B).
This study aims to see if puxitatug samrotecan 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