This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: * Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. * Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. * Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
Epidermal growth factor receptor inhibitor antineoplastic agent
HER2/neu receptor inhibitor
UCSD Moores Cancer Center
San Diego, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Incidence of dose-limiting toxicity (DLT)
The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).
Time frame: 28 days
Objective-response rate (ORR)
Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.
Time frame: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
Pharmacokinetics (PK) of FATE-NK100
The PK of FATE-NK100, as assessed by the proportion of lymphocytes in peripheral blood that are of donor/product origin at the specified time points.
Time frame: 0 days, 1 day, 3 days, 5 days, 8 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.