This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
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 epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.
Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from >3 months to ≤6 months after the last dose of platinum therapy.
Participants who have received >1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within <3 months of the final dose of first line platinum containing chemotherapy.
Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization, except for basal cell or squamous cell carcinomas of the skin, 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 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.
Has untreated brain or CNS metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases). Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to date of C1D1 are not excluded from participation.
Parallel
Mocertatug rezetecan
DrugMocertatug rezetecan will be administered
Paclitaxel
DrugPaclitaxel will be administered
Pegylated liposomal doxorubicin (PLD)
DrugPLD will be administered
Topotecan
DrugTopotecan will be administered
Gemcitabine
DrugGemcitabine will be administered
Pembrolizumab
DrugPembrolizumab will be administered
Bevacizumab
DrugBevacizumab will be administered
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) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first
Objective response rate (ORR) by BICR
ORR is defined as the percentage of participants with best overall response of either complete response (CR) or partial response (PR) per RECIST 1.1 by BICR assessment
Duration of Response (DOR) by BICR
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented Progressive Disease (PD) per RECIST 1.1 by BICR assessment or death due to any cause, whichever occurs first
ORR by investigator assessment
ORR is defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by investigator assessment
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GlaxoSmithKline
Lead sponsor
GOG, ENGOT, APGOT
Collaborator
