A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumor
- Study HIC#:2000036812
- Last Updated:12/20/2024
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.
Contact Us
For more information about this study, including how to volunteer, contact:
Michael Hurwitz
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Eligibility Criteria
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
