Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call
1-800-KARMANOS (1-800-527-6266)
or request an appointment below
Back to Results
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 Tumors
Cancer Categories
Breast,Gastrointestinal (GI),Head and Neck,Lung
Karmanos Trial ID
2023-100
NCT ID
NCT06241456
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Hadeel
Assad, M.D.
Oncology - Medical
View Profile
Objective:
Primary Objectives:
To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine
To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine
Secondary Objectives:
To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine
To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine
Request an Appointment
Refer a Patient
NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
Get Directions
Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions
Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast; Lip, Oral Cavity and Pharynx; Lung; Pancreas; Stomach
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
CAR-T, Chemotherapy, Immunotherapy
Drugs
Bendamustine; Cetuximab; Cisplatin; Cyclophosphamide; Docetaxel; FT825; Fludarabine Phosphate
Loading...