A randomized, open-label, multicenter, Phase 3 study to investigate mocertatug rezetecan compared with standard of care in participants with platinum- resistant ovarian cancer.

Ovarian Neoplasms

PFS, defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by BICR assessment or death from any cause, whichever occurs first, OS, defined as the time from the date of randomization to the date of death due to any cause

PFS, 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, ORR, defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by BICR assessment, DOR, 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 PD per RECIST 1.1 by BICR assessment or death due to any cause, whichever occurs first, ORR, defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by investigator assessment, DOR, defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first, PFS2, defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for PFS, or death from any cause, whichever occurs first, Incidence of TEAEs, AESIs, and TESAEs, Incidence of TEAEs/AESI/TESAEs leading to dose modifications (e.g., dose delay) or study intervention discontinuation, Changes in vital signs, laboratory tests (hematology and clinical chemistry), and ECG, PK concentration of Mo-Rez (conjugated antibody and free payload), Incidence of ADA and nAb and summary of ADA titers, Change from baseline as assessed by the EORTC QLQ-C30 (domains: GHS/QoL, physical functioning, role functioning), Change from baseline as assessed by the EORTC QLQ-OV28 on the abdominal/gastrointestinal symptom domain, TTD defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28, TTD defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on any of the following EORTC QLQ-C30 domains: physical functioning, role functioning and GHS/QoL, Maximum post-baseline PRO-CTCAE score for each frequency, severity and/or interference of symptomatic AEs as measured by the PRO-CTCAE, CA-125 response rate assessed by (GCIG) criteria

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