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

a study on HER2 Stomach Cancer Colorectal Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Solid Tumor Breast Cancer Hepatocellular Carcinoma Liver Cancer Lung Cancer Non-Small Cell Lung Cancer Kidney Cancer Renal Cell Carcinoma Pancreatic Cancer Melanoma Skin Cancer/Melanoma

Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

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.

Keywords

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 Solid Tumor HER2 EGFR Advanced Solid Tumor Breast Cancer Head and Neck Cancer Gastric Cancer HER2 Positive EGFR Positive EGFR+ HER2+ Immunotherapy NK cell therapy Natural killer cell therapy antibody-dependent cell-mediated cytotoxicity ADCC Renal cancer Carcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Carcinoma, Squamous Cell Stomach Neoplasms Carcinoma, Renal Cell Squamous Cell Carcinoma of Head and Neck Neoplasms Trastuzumab Cetuximab Antibodies Immunoglobulins Antibodies, Monoclonal FATE-NK100

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

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

Locations

  • UCSD Moores Cancer Center accepting new patients
    San Diego California 92037 United States
  • Baylor Scott & White Research Institute accepting new patients
    Dallas Texas 75246 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fate Therapeutics
Links
GSK 3 inhibition drives maturation of NK cells and enhances their antitumor activity
ID
NCT03319459
Phase
Phase 1
Study Type
Interventional
Last Updated