FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
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.
- 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.
- 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
Name Not Available
Name Not Available
Trial Phase & Type
Secondary IDs NCI-2017-02242
Clinicaltrials.gov ID NCT03319459