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
Parallel
FT825
DrugFT825 will be administered as an intravenous (IV) infusion at planned dose levels.
Fludarabine
DrugFludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
DrugCyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
DrugBendamustine will be administered as an IV infusion at planned dose levels.
Docetaxel
DrugDocetaxel will be administered as an IV infusion at planned dose levels.
Cisplatin
DrugCisplatin will be administered as an IV infusion at planned dose levels.
Cetuximab
DrugCetuximab will be administered as an IV infusion at planned dose levels.
Number of participants with dose limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be reported.
Severity of AEs
Severity of AEs will be determined according to appropriate rating scales for the type of event reported.
Investigator-Assessed Overall Response Rate (ORR)
ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1).
Investigator-Assessed Duration of Response (DOR)
DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1.
Progression-Free Survival (PFS)
PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1.
Overall Survival (OS)
OS defined as the time from first dose of study intervention to death from any cause.
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