Clinical trial NCT03319459: FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
Official title: FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HER2 Positive Gastric Cancer
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
EGFR Positive Solid Tumor
Advanced Solid Tumors
HER2-positive Breast Cancer
Hepatocellular Carcinoma
Non Small Cell Lung Cancer
Renal Cell Carcinoma
Pancreatic Cancer
Melanoma
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
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: 28 days
Secondary outcomes:
measure: Objective-response rate (ORR)
timeFrame: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
measure: Pharmacokinetics (PK) of FATE-NK100
timeFrame: 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
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital
state: Ohio
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: Fate Therapeutics
name: Jeff Chou, MD
role: STUDY_DIRECTOR
References:
citation: Cichocki F, Valamehr B, Bjordahl R, Zhang B, Rezner B, Rogers P, Gaidarova S, Moreno S, Tuininga K, Dougherty P, McCullar V, Howard P, Sarhan D, Taras E, Schlums H, Abbot S, Shoemaker D, Bryceson YT, Blazar BR, Wolchko S, Cooley S, Miller JS. GSK3 Inhibition Drives Maturation of NK Cells and Enhances Their Antitumor Activity. Cancer Res. 2017 Oct 15;77(20):5664-5675. doi: 10.1158/0008-5472.CAN-17-0799. Epub 2017 Aug 8.