Study on Invikafusp Alfa and Sacituzumab Govitecan for Advanced Solid Tumors

Inclusion Criteria

• Have a type of cancer that can be measured using scans or physical examination.
• Have one of the following types of cancer:
  • Metastatic Triple-Negative Breast Cancer (mTNBC) that has progressed or returned.
  • Hormone Receptor Positive/HER2 Negative Metastatic Breast Cancer (HR+/HER2- mBC) that has progressed or returned.
• If cancer has spread to the brain, it must have been treated and stable for at least 14 days without ongoing treatment like surgery, radiation, or high-dose steroids.

Exclusion Criteria

• Have a history of autoimmune diseases, except for certain conditions like vitiligo, psoriasis, or well-controlled thyroid issues.
• Have had major surgery or a serious injury within the last 8 weeks.
• Have unhealed wounds from surgery or injury.
• Have significant heart, digestive, lung, or inflammatory health issues.
• Have an active infection needing treatment within the last 7 days.
• Have received a live virus vaccine within the last 4 weeks (flu shots are allowed).
• Have uncontrolled HIV, hepatitis B, or hepatitis C.
• Have another type of cancer that is not in remission for at least 1 year, except for certain non-threatening cancers.
• Are pregnant, planning to become pregnant, or breastfeeding.
• Are taking more than 10 mg of prednisone or similar drugs within the last 7 days, unless for specific allergic reactions. Topical, eye, inhaled, or nasal steroids are allowed.