BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

Exclusion Criteria

• •Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
• •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •Has cardiac or renal amyloid light-chain amyloidosis.
• •Has had clinically significant lung disease requiring systemic corticosteroid treatment within the last 6 months of enrollment.
• •Has an active, known, or suspected autoimmune disease.
• •Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.
• •Has presence of chronic graft versus host disease.
• •Has had an allogenic tissue/solid organ transplant.
• •Has uncontrolled or significant cardiovascular disease.
• •Has a known additional malignancy of another type, except for adequately treated cone-biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ), adequately controlled superficial bladder cancer, and basal or squamous cell carcinoma of the skin.
• •Has a diagnosis of primary or acquired immunodeficiency disorder or is taking any other form of immunosuppressive therapy.