A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Mocertatug rezetecan
  • Paclitaxel
  • Doxorubicin

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

GlaxoSmithKline

Lead sponsor

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

GOG Foundation

Collaborator

Asia-Pacific Gynecologic Oncology Trials Group

Collaborator