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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319459
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Tracking Information
First Submitted Date  ICMJE October 19, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE January 18, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Incidence of dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
Incidence of dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
• 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).
Change History Complete list of historical versions of study NCT03319459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Objective-response rate (ORR) [ Time Frame: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days. ]
    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.
  • Pharmacokinetics (PK) of FATE-NK100 [ Time Frame: 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 ]
    The PK of FATE-NK100, as assessed by the proportion of lymphocytes in peripheral blood that are of donor/product origin at the specified time points.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
  • Objective-response rate (ORR) [ Time Frame: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, 393 days, 449 days, 505 days, 561 days, 617 days, 673 days and 729 days. ]
    • 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.
  • 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 ]
    • Duration of FATE-NK100 persistence: defined as duration from Day 1 to undetectable levels of FATE-NK100 cells per uL blood.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
Official Title  ICMJE FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: FATE-NK100
    FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
  • Drug: Cetuximab
    Epidermal growth factor receptor inhibitor antineoplastic agent
    Other Name: Erbitux
  • Drug: Trastuzumab
    HER2/neu receptor inhibitor
    Other Name: Herceptin
Study Arms  ICMJE
  • Experimental: Regimen A
    FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
    Intervention: Drug: FATE-NK100
  • Experimental: 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.
    Interventions:
    • Drug: FATE-NK100
    • Drug: Trastuzumab
  • Experimental: Regimen C
    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.
    Interventions:
    • Drug: FATE-NK100
    • Drug: Cetuximab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03319459
Other Study ID Numbers  ICMJE NK-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fate Therapeutics
Study Sponsor  ICMJE Fate Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sarah Cooley, MD Fate Therapeutics
PRS Account Fate Therapeutics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP