Study on the Safety, Tolerability, and Effectiveness of Farletuzumab Ecteribulin for Certain Cancer Types

Inclusion Criteria

• Age 18 or older.
• For Dose-Escalation: Women with triple-negative breast cancer, endometrial cancer, or ovarian cancer, or men and women with non-small cell lung cancer.
• Specific cancer types include:
  • Triple-negative breast cancer: Must have metastatic cancer that is negative for certain receptors and previously treated with at least one therapy.
  • Non-small cell lung cancer: Must have metastatic adenocarcinoma that has not responded to previous treatments and no other standard therapy options.
  • Endometrial cancer: Must have advanced, recurrent, or metastatic cancer that has not responded to at least one platinum-based or immunotherapy regimen.
  • Ovarian, primary peritoneal, or fallopian tube cancer: Must have high-grade serous epithelial cancer that is resistant to platinum-based treatments.
• Must have measurable disease and available tumor tissue for testing.
• Must have adequate kidney, liver, and bone marrow function.
• Must be expected to survive at least 3 months after starting the study drug.
• Must not have had certain treatments or surgeries within a specified time before starting the study drug.
• Must be willing to comply with study requirements and provide informed consent.

Exclusion Criteria

• Certain types of endometrial or soft tissue sarcomas.
• Previous treatment with folate receptor-targeting agents.
• Platinum-refractory ovarian cancer.
• Participation in another clinical study or use of investigational drugs recently.
• Brain or subdural metastases unless stable and treated.
• Meningeal carcinomatosis.
• Other invasive cancers treated within the last 2 years.
• Significant heart problems or abnormal ECG.
• Active viral hepatitis or HIV.
• Pregnant or breastfeeding women.
• Women of childbearing potential not using effective contraception.
• Men not using effective contraception if their partner is of childbearing potential.
• Certain lung function abnormalities or history of lung disease.
• Active infections or recent live vaccinations.
• Known allergies to study drugs or components.
• Any condition that would interfere with study participation.
• Use of prohibited medications.