This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.
Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
Has histologically confirmed endometrial carcinoma including but not limited to endometroid, serous, clear cell, and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted.
Adjuvant ± neo-adjuvant therapy counts as one line of treatment.
Maintenance therapy is considered part of the preceding line and does not count as an independent line.
Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer.
Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.
Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Parallel
Mocertatug rezetecan
DrugMocertatug rezetecan will be administered
Paclitaxel
DrugPaclitaxel will be administered
Doxorubicin
DrugDoxorubicin will be administered
Objective response rate (ORR) by BICR
ORR is defined as the percentage of participants with best overall confirmed response of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR)
Progression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) or death from any cause, whichever occurs first per RECIST 1.1 by BICR assessment
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
ORR by investigator assessment
ORR is defined as the percentage of participants with best overall confirmed response of either CR or PR per RECIST 1.1 by investigator assessment
Duration of Response (DOR) by BICR
DOR is defined as the time from the date of the first documented objective response (CR or PR) that is subsequently confirmed to the date of first documented PD or death due to any cause, whichever occurs first per RECIST 1.1 by BICR assessment
DOR by investigator assessment
DOR is defined as the time from the date of first documented objective response (CR or PR) that is subsequently confirmed to the date of first documented PD or death due to any cause, whichever occurs first per RECIST 1.1 by investigator assessment
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GlaxoSmithKline
Lead sponsor
ENGOT, GOG, APGOT
Collaborator