Study on Sacituzumab Govitecan for Patients with Advanced Cancer that has Spread

Inclusion Criteria

• Have advanced cancer that has spread (Stage IV) or is locally advanced, specifically:
  • Non-small cell lung cancer (NSCLC) that has worsened after previous treatments with platinum-based chemotherapy and PD-(L)1 therapy.
  • Head and neck squamous cell carcinoma (HNSCC) that has worsened after similar treatments.
  • Endometrial cancer that has worsened after similar treatments.
  • Extensive stage small cell lung cancer (SCLC) that has worsened after similar treatments, with no more than one previous treatment allowed.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate blood cell counts without needing recent transfusions or growth factors.
• Have good liver and kidney function, with a creatinine clearance of at least 30 mL/min.
• Have a life expectancy of at least 3 months.
• Have measurable cancer as seen on CT or MRI scans according to standard criteria.

Exclusion Criteria

• Have received any anti-cancer biologic agent within 4 weeks before starting the study or other cancer treatments within 2 weeks before starting the study.
• Have not fully recovered from side effects of previous treatments.
• Have previously been treated with topoisomerase I inhibitors.
• Have another active cancer.
• Have active cancer that has spread to the brain or spinal cord, unless previously treated and stable for at least 4 weeks, with no new symptoms or growth, and taking no more than 20 mg/day of prednisone.
• Have cancer in the brain's lining (carcinomatous meningitis), regardless of stability.
• Other specific criteria may apply as defined by the study protocol.