Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

Exclusion criteria

• ✕. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of current study drug.
• ✕. Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug; for tyrosine kinase inhibitor or similar within 4 × half-life prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central nervous system disease, with Sponsor approval.
• ✕. Participants who have received prior CTLA-4 therapy may be enrolled in selected indications upon agreement with the Sponsor.
• ✕. Persistent toxicity of NCI CTCAE version 5.0 Grade \> 1 severity that is related to prior therapy. Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (for example, diabetes or hypertension) may be permitted with sponsor approval.
• ✕. Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
• ✕. History of:
• ✕. Severe (Grade ≥ 3) hypersensitivity reaction to a fully human monoclonal antibodies
• ✕. Immune-related adverse event requiring treatment with systemic steroids for \> 7 days excluding Grade 1 or 2 rash.