A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

Exclusion Criteria

• •History of severe hypersensitivity reactions to other mAbs.
• •Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or breast).
• •For subjects enrolled in the dose escalation phase, having received prior anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with AK112 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids
• •Receiving any immunotherapy, conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose
• •Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment (hormones use for non-cancer related conditions is acceptable).
• •Subjects with clinically significant cardiovascular disease
• •Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
• •Current or recent use of aspirin (\> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
• •Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of AK112
• •Active or prior documented autoimmune disease within the past 2 years or conditions not expected to recur in the absence of an external trigger)
• •Active or prior documented inflammatory bowel disease
• •History of primary immunodeficiency.
• •History of organ transplant.
• •Known allergy or reaction to any component of the AK112 formulation.
• •History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
• •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1
• •Major surgical procedure within 30 days prior to the first dose of AK112 or still recovering from prior surgery.
• •Known history of HIV.