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

Inclusion Criteria:

Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
Presence of measurable disease by RECIST 1.1
Life expectancy of at least 3 months.
Provision of signed and dated informed consent form (ICF).
Stated willingness to comply with study procedures and duration.

Exclusion Criteria:

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.
Eastern Cooperative Oncology Group (ECOG) performance status >2.
Evidence of insufficient organ function as determined by the protocol.
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.

Have central nervous system disease (CNS) as follows:

Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
Myocardial infarction (MI) within 6 months of Screening Visit.
Severe asthma.
Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
Uncontrolled infections.
Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.