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Completed

NCT Number: NCT03319459

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

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.

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Key information

Conditions

HER2 Positive Gastric Cancer Adenocarcinoma Advanced Solid Tumors Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms EGFR Positive Solid Tumor Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms HER2-positive Breast Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non Small Cell Lung Cancer Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCSD Moores Cancer Center, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
  • Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
  • Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
  • Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
  • Presence of measurable disease by RECIST 1.1
  • Life expectancy of at least 3 months.
  • Provision of signed and dated informed consent form (ICF).
  • Stated willingness to comply with study procedures and duration.

Exclusion criteria

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Evidence of insufficient organ function as determined by the protocol.
  • 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.
  • Have central nervous system disease (CNS) as follows:
  • Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
  • MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
  • Myocardial infarction (MI) within 6 months of Screening Visit.
  • Severe asthma.
  • Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
  • Uncontrolled infections.
  • Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.

Treatment and study plan

FATE-NK100

Drug

FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity

Cetuximab

Drug

Epidermal growth factor receptor inhibitor antineoplastic agent

Other names: Erbitux

Trastuzumab

Drug

HER2/neu receptor inhibitor

Other names: Herceptin

Primary outcomes

  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 outcomes

  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. 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.

Sponsors and collaborators

Lead sponsor

Fate Therapeutics

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2017
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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