Mirro center logo
Return to Clinical Trials Search Results

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 an

Primary Objectives To demonstrate the superiority of AZD8205 relative to Physician s choice of chemotherapy by assessment of PFS per BICR. To demonstrate the superiority of AZD8205 relative to Physician s choice of chemotherapy by assessment of OS. Secondary Objectives To assess the efficacy of AZD8205 relative to Physician s choice of chemotherapy by assessment of ORR per BICR. To demonstrate the efficacy of AZD8205 relative to Physician s choice of chemotherapy by assessment of DoR per BICR. To demonstrate the efficacy of AZD8205 relative to Physician s choice of chemotherapy by assessment of DCR in all randomized participants. To demonstrate the efficacy of AZD8205 relative to Physician s choice of chemotherapy by assessment change in tumor size (ie, tumor shrinkage). To assess the safety and tolerability of AZD8205 compared to Physician s choice of chemotherapy in all randomized participants who received at least 1 dose of study treatment. To describe patient-reported treatment symptoms of AZD8205 compared to Physician s choice of chemotherapy. To assess the impact of AZD8205 compared to Physician s choice of chemotherapy on symptoms and functioning associated with endometrial cancer. To explore the impact of AZD8205 compared to Physician s choice of chemotherapy on health status. To investigate the immunogenicity of AZD8205. To investigate the PK of AZD8205.

Phase

III

Recruitment Status

Current Studies