Clinical Trials /

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

NCT03319459

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NK-101
  • NCT ID: NCT03319459

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
  • Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Pancreas Cancer

Interventions

DrugSynonymsArms
FATE-NK100Regimen A
CetuximabErbituxRegimen C
TrastuzumabHerceptinRegimen B

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Regimen AExperimentalFATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
  • FATE-NK100
Regimen BExperimentalFATE-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.
  • FATE-NK100
  • Trastuzumab
Regimen CExperimentalRegimen 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.
  • FATE-NK100
  • Cetuximab

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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicity (DLT)
Time Frame:28 days
Safety Issue:
Description:• The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).

Secondary Outcome Measures

Measure:Objective-response rate (ORR)
Time Frame:28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
Safety Issue:
Description:• Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.
Measure:FATE-NK100 persistence
Time Frame:0 days, 1 day, 3 days, 5 days, 8 days, 10 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days
Safety Issue:
Description:• Duration of FATE-NK100 persistence: defined as duration from Day 1 to undetectable levels of FATE-NK100 cells per uL blood.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fate Therapeutics

Trial 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

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