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

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

Conditions2

Locations14 sites

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