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New treatment option for Advanced Solid Tumor
Official title FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06241456
What this study is testing
What is FT825?
FT825 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as ONO-8250.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Active bacterial, fungal, or viral infections
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; La Jolla, California, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.