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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319459
• Other study ID #: NK-101
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: November 2021
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 15, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Colorectal Cancer
• Colorectal Neoplasms
• EGFR Positive Solid Tumor
• Head and Neck Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• HER2 Positive Gastric Cancer
• HER2-positive Breast Cancer
• Melanoma
• Neoplasms
• Non Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Stomach Neoplasms

Intervention

Drug:
• FATE-NK100
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
• Cetuximab
Epidermal growth factor receptor inhibitor antineoplastic agent
• Trastuzumab
HER2/neu receptor inhibitor

Locations

Country	Name	City	State
United States	The Ohio State University James Cancer Hospital	Columbus	Ohio
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	University of Minnesota	Minneapolis	Minnesota
United States	UCSD Moores Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT)	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	Objective-response rate (ORR)	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.
Secondary	Pharmacokinetics (PK) of FATE-NK100	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

External Links

•   GSK 3 inhibition drives maturation of NK cells and enhances their antitumor activity