FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Registration Number
- NCT06241456
- Lead Sponsor
- Fate Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 351
Inclusion Criteria:<br><br> - Histopathological or cytologically confirmed locally advanced or metastatic cancer<br> that meets protocol-defined criteria<br><br> - Disease that is not amenable to curative therapy, with prior therapies defined by<br> specific tumor types<br><br> - Contraceptive use by women and men should be consistent with local regulations<br> regarding the methods of contraception for those participating in clinical studies<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1<br><br> - Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to<br> start of first study intervention<br><br> - Anticipated life expectancy of at least 3 months<br><br>Exclusion Criteria:<br><br> - Females who are pregnant or breastfeeding<br><br> - Evidence of inadequate organ function<br><br> - Clinically significant cardiovascular disease<br><br> - Known active central nervous system (CNS) involvement by malignancy<br><br> - Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or<br> neurodegenerative disease or receipt of medications for these conditions within 2<br> years prior to study enrollment<br><br> - Active bacterial, fungal, or viral infections<br><br> - Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular<br> therapy, or a FATE investigational human induced pluripotent stem cell (iPSC)<br> product<br><br> - History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that<br> required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot<br> be ruled out based on imaging at screening<br><br> - Any history of Grade =3 immune-related AE or Grade =2 eye toxicity attributed to<br> prior cancer immunotherapy, other than endocrinopathy managed with replacement<br> therapy or asymptomatic elevation of serum amylase or lipase<br><br> - Active or history of autoimmune disease or immune deficiency<br><br> - Receipt of an allograft organ transplant
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLTs);Number of participants with treatment-emergent adverse events (TEAEs);Severity of AEs
- Secondary Outcome Measures
Name Time Method Investigator-Assessed Overall Response Rate (ORR);Investigator-Assessed Duration of Response (DOR);Progression-Free Survival (PFS);Overall Survival (OS);Plasma Concentration of FT825