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A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Treatment of Physician's Choice in Participants with B7-H4-Positive Advanced/Metastatic Endometrial Cancer Who Progressed After Platinum and Anti-PD-1/Anti-PD-L1 Therapy

Cancer
Jill Tseng
Corpus Uteri

Study Description

This study is to learn more about the experimental drug called Puxitatug Samrotecan (AZD8205) and also to better understand the studied disease (advanced/metastatic endometrial cancer) and associated health problems.

In this study, AZD8205 monotherapy (use of a single study drug alone) will be compared with the study doctor’s choice of chemotherapy (doxorubicin or paclitaxel) in participants with advanced/metastatic endometrial cancer with a certain protein on the surface of the tumor cells who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy (either separately or in combination).

Eligibility

  • Adults 18+

-Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma

-Documented B7-H4 expression by prospective central testing must be available prior to screening

-The participant had uterine sarcomas

-Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

-Participants with brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids

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