Advanced Solid Tumors, Colorectal Cancer, EGFR Positive Solid Tumor, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma, HER2-positive Breast Cancer, HER2 Positive Gastric Cancer, Melanoma, Non Small Cell Lung Cancer, Pancreatic Cancer, Renal Cell Carcinoma
Conditions
Keywords
Solid Tumor, HER2, EGFR, Advanced Solid Tumor, Breast Cancer, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Gastric Cancer, HER2 Positive, EGFR Positive, EGFR+, HER2+, Immunotherapy, NK cell therapy, Natural killer cell therapy, antibody-dependent cell-mediated cytotoxicity, ADCC, Non small cell lung cancer, Renal cancer
Brief summary
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.
Interventions
DRUGFATE-NK100
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
DRUGCetuximab
Epidermal growth factor receptor inhibitor antineoplastic agent
DRUGTrastuzumab
HER2/neu receptor inhibitor
Sponsors
Fate Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors 2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors 3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors 4. Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched 5. Presence of measurable disease by RECIST 1.1 6. Life expectancy of at least 3 months. 7. Provision of signed and dated informed consent form (ICF). 8. Stated willingness to comply with study procedures and duration.
Exclusion criteria
1. Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study. 2. Eastern Cooperative Oncology Group (ECOG) performance status \>2. 3. Evidence of insufficient organ function as determined by the protocol. 4. Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab. 5. Have central nervous system disease (CNS) as follows: 1. Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases. 2. MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months. 6. Myocardial infarction (MI) within 6 months of Screening Visit. 7. Severe asthma. 8. Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29. 9. Uncontrolled infections. 10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | 28 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective-response rate (ORR) | 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days. | 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. |
| Pharmacokinetics (PK) of FATE-NK100 | 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 | 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. |
Countries
United States
Outcome results
None listed