AKESO AK112-01: This phase 1 trial is evaluating the effectiveness and safety of a novel immunotherapy (AK112) for the treatment of patients with advanced solid tumoursA Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects with Advanced Solid Tumors

Exclusion

• 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.
• Known active hepatitis B or C infections. Note: Subjects with HCC and positive HBsAg result are eligible if the subjects were treated with antiviral therapy and HBV viral load less than 500 IU/mL prior to first dose of AK112.
• An active infection requiring systemic therapy
• Received live attenuated vaccination within 30 days prior to the first dose of AK112.