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

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ClinicalTrials.gov Identifier: NCT03319459
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

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.

Condition or disease Intervention/treatment Phase
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 Drug: FATE-NK100 Drug: Cetuximab Drug: Trastuzumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Experimental: Regimen A
FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
Drug: FATE-NK100
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity

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.
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: Trastuzumab
HER2/neu receptor inhibitor
Other Name: Herceptin

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.
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319459


Contacts
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Contact: Sara Weymer 858-875-1800 clinical@fatetherapeutics.com
Contact: Muhi Sirajuddin 858-875-1800

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Manish Patel, DO         
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Carlos Becerra, MD         
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Peter Langecker, MD, PhD Fate Therapeutics

Additional Information:
Publications:
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT03319459     History of Changes
Other Study ID Numbers: NK-101
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fate Therapeutics:
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

Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Colorectal Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Hepatocellular
Stomach Neoplasms
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Squamous Cell Carcinoma of Head and Neck
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Squamous Cell
Adenocarcinoma
Liver Neoplasms
Liver Diseases
Stomach Diseases
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases