A randomized, open-label, multicenter, Phase 3 study to investigate mocertatug rezetecan compared with chemotherapy in participants with endometrial cancer after platinum-based chemotherapy and immunotherapy

Condition studied

Neoplasms, Endometrial

Investigational medicinal product(s)

Eligibility

Primary endpoint

ORR, defined as the percentage of participants with best overall confirmed response of either CR or PR per RECIST 1.1 by BICR assessment 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

Endpoint detail

1. OS, defined as the time from the date of randomization to the date of death due to any cause, 2. ORR, defined as the percentage of participants with best overall confirmed response of either CR or PR per RECIST 1.1 by investigator assessment., 3. DOR, defined as the time from the date of the first documented objective response (CR or PR) that is subsequently confirmed (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, 4. DOR, defined as the time from the date of first documented objective response (CR or PR) that is subsequently confirmed (per RECIST 1.1 by investigator assessment) to the date of first documented PD (per RECIST 1.1 investigator assessment) or death due to any cause, whichever occurs first, 5. 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 due to any cause, whichever occurs first, 6. Incidence of TEAEs, AESIs, and TESAEs Incidence of TEAEs/AESIs/TESAEs leading to dose modifications (e.g., dose delay) or study intervention discontinuation Changes vital signs, laboratory tests (hematology and clinical chemistry), and ECG, 7. Change from baseline in global health status/QoL, physical functioning, role functioning as assessed by the EORTC QLQ-C30, 8. Change from baseline in lymphedema, urological symptoms, gastrointestinal symptoms, pain in back and pelvis as assessed by the EORTC QLQ-EN24, 9. TTD defined as the time from date of randomization to the date of first confirmed clinically meaningful deterioration on any of the following domains of the EORTC QLQ-EN24: lymphedema, urological symptoms, gastrointestinal symptoms, and pain in back and pelvis domains, 10. TTD defined as the time from date of randomization to the date of first confirmed clinically meaningful deterioration on any of the following domains of the EORTC QLQ-C30: Physical Functioning, Role Functioning, and global health status/QoL, 11. Maximum post-baseline score for each frequency, severity, and/or interference of symptomatic AEs as measured by the PRO-CTCAE, 12. Serum PK concentrations for Mo-Rez (conjugated antibody and free payload), 13. Incidence of ADA and nAb and summary of ADA titers against Mo-Rez