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

ID#: NCT06241456

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: January 05, 2024

End Date: May 01, 2044

Contact Information:
Fate Trial Disclosure
866-875-1800
Summary: 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.
Eligibility:

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
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