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

November 18, 2021 updated by: Fate Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • UCSD Moores Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University James Cancer Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fate Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

May 29, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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