Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer
This clinical trial is investigating IMGN151, an antibody-drug conjugate designed to precisely target and attack cancer cells. The study focuses on women with recurrent endometrial cancer and recurrent high-grade serous epithelial ovarian cancer, as well as similar cancers affecting the peritoneum (lining of the abdomen) and fallopian tubes. The trial is conducted in two phases: first, finding the safest and most effective dose, and second, testing that dose in more patients to further evaluate its effectiveness.
Main inclusion criteria: Patients must be women at least 18 years old with confirmed recurrent cancer of the types mentioned above. They must have tried standard treatments without success and have tumors that can be measured by imaging tests. Participants need adequate blood, liver, and kidney function, meaning enough white blood cells, platelets, and hemoglobin without recent transfusions or growth factors, good kidney function, liver enzymes within acceptable limits, and normal bilirubin levels. Any major surgery must be completed at least 4 weeks before starting the study drug, with recovery or stabilization from side effects. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 28 weeks after the last dose. Patients must be able to carry out daily activities with minimal restrictions and be willing to provide tumor tissue samples for testing.
Main exclusion criteria: The study excludes male patients, as it is specifically designed for women with gynecological cancers. Patients who are considered part of a vulnerable population are also excluded from participation.
Focus and goal: The primary goal is to determine the best dose of IMGN151 that can be safely given to patients and to evaluate how well it works in treating these recurrent cancers. Throughout the study, participants receive IMGN151 through an intravenous infusion directly into the bloodstream. The trial follows a structured approach starting with eligibility confirmation, moving through dose-escalation and expansion phases, with ongoing monitoring of side effects and cancer response. Patients will also use specific eye drops (Pred Forte 1% and Brimonidine Tartrate 0.2%) to manage any ocular symptoms or side effects that may occur during treatment.
Investigational drug: IMGN151 is an experimental antibody-drug conjugate that combines an antibody with a cancer-fighting drug. This design allows the medication to specifically target cancer cells while minimizing damage to healthy cells. The drug is delivered intravenously and is still in early stages of clinical research, with this trial focusing on establishing its safety, tolerability, and optimal dosing for future studies.
Austria
