Study Comparing Mocertatug Rezetecan with Chemotherapy for Endometrial Cancer After Previous Treatments
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT07286331
This clinical trial is testing a new drug, mocertatug rezetecan (Mo-Rez), to see if it works better than standard chemotherapy for treating endometrial cancer in patients who have already received platinum-based chemotherapy and immunotherapy. The study also aims to understand the safety and side effects of Mo-Rez compared to standard treatments.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how effective and safe the new drug mocertatug rezetecan (Mo-Rez) is for treating endometrial cancer compared to the usual chemotherapy treatments. Researchers want to see if Mo-Rez can better manage the cancer and what side effects it might have compared to the standard care.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old and legally able to consent to participate.
- Must have a confirmed diagnosis of endometrial cancer, including specific types like endometrioid, serous, clear cell, or carcinosarcoma.
- Must have had 1 to 2 previous treatments for endometrial cancer, or up to 3 if one was given before or after surgery.
- Must have cancer that has worsened after platinum-based chemotherapy and have received PD-1/PD-L1 therapy, unless unsuitable for such treatment.
- Must have a platinum-free interval of less than 12 months if only treated with platinum-based therapy after surgery.
- Must provide a tumor sample for testing a specific protein (B7-H4) before starting the study.
- Must have at least one measurable tumor.
- Must agree to use effective birth control during the study and for 8 months after the last dose if of childbearing potential.
- Must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
- Must be able to give informed consent and follow study requirements.
- Must have a performance status indicating good overall health (ECOG 0 or 1).
- Must have adequate organ function.
Exclusion Criteria
- Cannot have certain types of uterine cancer like uterine sarcomas or neuroendocrine cancer.
- Cannot have another cancer that has needed treatment in the last 3 years, except for certain skin cancers or in-situ cancers that have been treated.
- Cannot have had a bone marrow or organ transplant.
- Cannot have allergies to the study drugs or their components.
- Cannot have untreated or worsening brain or CNS metastases.
- Cannot have a history of lung disease or pneumonitis.
- Cannot have unresolved side effects from previous treatments, except for certain conditions like hair loss or stable conditions.
- Cannot have serious medical or psychiatric conditions that could interfere with the study.
- Cannot have had major surgery or certain treatments recently.
- Cannot have received certain investigational or anti-cancer drugs recently.
- Cannot have received a live vaccine recently.
- Cannot have certain infections like HIV with specific criteria, or active hepatitis B or C.
- Cannot have significant heart or kidney conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 35226 | Birmingham | Alabama |
| GSK Investigational Site | 68114-4108 | Omaha | Nebraska |
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