A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients with Advanced Cancer.

Exclusion Criteria

• •Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases. Definitively treated CNS metastases (e.g., radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
• •Participants with an active second malignancy. Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved \> 3 years prior to Screening are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
• •Significant cardiovascular/cerebrovascular disease, including myocardial infarction or transient ischemic attack (TIA) within 6 months prior to Day 1 of study drug administration.
• •Active infections, or uncontrolled infection requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment
• •Hemoglobin (Hb) \<9 g/dL, transfusion of red blood cells allowed to reach threshold target.
• •Neutrophils \<1500 /mm3.
• •Platelets \<100'000/mm3.
• •Liver: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5xULN, if due to liver metastasis or primary liver cancer, AST or ALT \>5x ULN.
• •Total bilirubin \> upper limit of normal (ULN) (in documented Gilbert's syndrome, direct bilirubin \> ULN).
• •International normalized ratio (INR) \>1.5xULN.
• •Serum creatinine \> ULN and estimated creatinine clearance \< 50 mL/min using the Cockcroft-Gault formula.
• •Confirmed replicating human immunodeficiency virus (HIV) or confirmed active (replicative) hepatitis B virus or hepatitis C virus infection. Patients with treated non-replicative disease are acceptable.
• •Evidence of hepatic cirrhosis with Child-Pugh score C.
• •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding \> Grade 2 that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
• •Major surgery or significant traumatic injury \<28 days prior to the first ANV419 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.
• •Severe altered mental status.
• •Pregnant or breastfeeding women.
• •Known hypersensitivity to any of the components of ANV419 or its formulation.
• •Concurrent therapy with any other investigational drug within one month prior to Day 1 of study drug administration.
• •Active untreated immune-related endocrinopathies untreatable with replacement. Prior immune related toxicities \> Grade 3 after treatment with immunostimulatory drugs (e.g., colitis, neuropathy) that have not completely resolved.
• •Chronic treatment with systemic immunosuppressive medications above 10 mg/day prednisolone equivalent for any reason.
• •Experienced unacceptable drug-related toxicity with prior ipilimumab treatment (defined as toxicities that required second line immunosuppression, ie, not controlled by steroids alone)
• •Received ipilimumab within 6 months prior to cycle 1 day 1.
• •Known hypersensitivity to ipilimumab or any of its excipients
• •Patients with active autoimmune disease or a history of autoimmune disease (other than vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism),
• •Symptomatic interstitial lung disease
• •Concomitant use of therapeutic anti-coagulation (e.g.to treat pulmonary embolus or deep vein thrombosis). Prophylactic anti-coagulation is permitted.