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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:January 18, 2018
End Date:October 2022
Contact:Sara Weymer
Email:clinical@fatetherapeutics.com
Phone:858-875-1800

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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.


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.
We found this trial at
4
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Columbus, Ohio 43210
Principal Investigator: Claire Verschraegen, MD
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3505 Gaston Avenue
Dallas, Texas 75246
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San Diego, California 91351
Principal Investigator: Sandip Patel, MD
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San Diego, CA
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