RecruitingNeoplasms, Endometrial
A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)
Eligible age
18+ yrs
Accepts
Women
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ Participants are eligible to be included in the study only if all of the following criteria apply:
- ✓ 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.
- ✓ Has undergone at least 1 and no more than 2 lines of prior systemic treatment for EC. Up to 3 lines of prior systemic treatment are acceptable if one line was administered in the adjuvant/neo-adjuvant setting. The definition of prior lines of therapy is as follows:
- ✓ 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.
- ✓ Switching to another agent within the same class due to toxicity (without disease progression) is considered part of the same line of therapy.
- ✓ Unplanned addition or switching to a new anti-cancer therapy in a different class is considered a separate line of therapy.
You may not qualify if…
- ✕ Participants are excluded from the study if any of the following criteria apply:
- ✕ 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.
- ✕ Has untreated brain or Central nervous system (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 before date of C1D1 are not excluded from participation.
- ✕ Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.
- ✕ Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo and endocrinopathy managed with replacement therapy, or that the investigator, with the agreement of the sponsor, considers to be stable or not clinically relevant for the tolerability of study intervention in the current clinical study.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07286331 · last updated 2026-10-02