a study of incmga00012, incb001158, and the combination in japanese participants with advanced solid tumors

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors

Summary: the purpose of this study is to assess the safety and tolerability and the pharmacokinetics (pk) of incmga00012 (pd-1 inhibitor), incb001158 (arginase inhibitor), and the combination in japanese participants with advanced solid tumor malignancies.


Eligibility criteria:
inclusion criteria: * participant is japanese * histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy. * participants with nonevaluable lesions are allowed. * life expectancy \> 3 months. * eastern cooperative oncology group performance status 0 to 1. * female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration. * female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study. * male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study. exclusion criteria: * receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-c or nitrosoureas; 7 days for tyrosine kinase inhibitors. * radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is \> 30 gy. * toxicity of prior therapy and/or complications from surgical intervention that has not recovered to ≤ grade 1 or baseline within 7 days before starting study drug treatment (with the exception of anemia not requiring transfusion support and any grade of alopecia). note: endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor. * receipt of prior systemic treatment with an arginase inhibitor * immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones). * active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent). * known active central nervous system metastases and/or carcinomatous meningitis. * known active hepatitis a virus, hepatitis b virus, or hepatitis c virus infection. * known hiv infection. * active infections requiring systemic therapy. * known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity ≥ grade 3, or severe reaction, to study treatments or any of their excipients or additives. * participants with impaired cardiac function or clinically significant cardiac disease. * evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease. * participant is pregnant or breastfeeding.

Keywords: advanced solid tumors metastatic solid tumors incmga00012 incb001158 japan pd-1 inhibitor arginase inhibitor