This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Females who are pregnant or breastfeeding
Evidence of inadequate organ function
Clinically significant cardiovascular disease
Known active central nervous system (CNS) involvement by malignancy