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

Status: Active


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.

Eligibility Criteria

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.

Locations & Contacts


San Diego
University of California San Diego
Status: Active
Name Not Available


University of Minnesota / Masonic Cancer Center
Status: Active
Name Not Available


Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type


Lead Organization

Lead Organization
Fate Therapeutics

Trial IDs

Primary ID NK-101
Secondary IDs NCI-2017-02242
Clinicaltrials.gov ID NCT03319459