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.
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.
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
60 mg/m2 on Day 1 Q3W Route of administration: IV
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Capital Federal, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad de Buenos Aires, Argentina
Córdoba, Argentina
Córdoba, Argentina
Cuidad Autónoma de Buenos Aire, Argentina
La Rioja, Argentina
Pergamino, Argentina
Viedma, Argentina
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