FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors

Inclusion Criteria: * 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 * Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention * Anticipated life expectancy of at least 3 months Exclusion Criteria: * Females who are pregnant or breastfeeding * Evidence of inadequate organ function * Clinically significant cardiovascular disease * Known active central nervous system (CNS) involvement by malignancy * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment * Active bacterial, fungal, or viral infections * Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening * Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase * Active or history of autoimmune disease or immune deficiency * Receipt of an allograft organ transplant