Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.

Inclusion Criteria:Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluationsAge ≥ 18 years and ≤ 75 yearsHistologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy existsMeasurable lesion based on RECIST v1.1ECOG status of 0 or 1Life expectancy ≥ 3 monthsAdequate organ functionWomen of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatmentExclusion Criteria:Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intentCurrently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional studyReceived systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational productIn addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanismPrior therapy targeting CD73 or CD39 or the adenosine signalling pathwayTreatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational productCurrent dependency on systemic therapy with glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational productPresence of spinal cord compression or active brain metastasesUncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainageHistory or presence of a serious hemorrhage or known bleeding tendency within 3 monthsActive autoimmune disease that has required systemic treatment in past 2 yearsClinically significant cardiovascular diseaseHistory of interstitial lung disease or noninfectious pneumonitisReceived systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational productMajor surgical procedure or serious trauma within 28 days prior to the first dose of investigational productHistory of immunodeficiency, human immunodeficiency virus infection (HIV)Active tuberculosis or syphilis infectionHistory of organ transplantation or allogeneic haematopoietic stem cell transplantationToxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results