FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

Brief summary public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Drug: FATE-NK100. FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity

Intervention public domain (ClinicalTrials.gov)

Drug: Cetuximab (Erbitux). Epidermal growth factor receptor inhibitor antineoplastic agent

Intervention public domain (ClinicalTrials.gov)

Drug: Trastuzumab (Herceptin). HER2/neu receptor inhibitor

Arm public domain (ClinicalTrials.gov)

Regimen A (experimental): FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.

Arm public domain (ClinicalTrials.gov)

Regimen B (experimental): 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.

Arm public domain (ClinicalTrials.gov)

Regimen C (experimental): 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.

Eligibility public domain (ClinicalTrials.gov)

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.