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

Sponsor

Fate Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03319459

Collaborator

(none)

Enrollment

Locations

Arms

34.9

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Non Small Cell Lung Cancer Renal Cell Carcinoma Pancreatic Cancer Melanoma	Drug: FATE-NK100 Drug: Cetuximab Drug: Trastuzumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 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 :

Jan 18, 2018

Actual Primary Completion Date :

May 29, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of dose-limiting toxicity (DLT) [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

Objective-response rate (ORR) [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.
Pharmacokinetics (PK) of FATE-NK100 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Moores Cancer Center	San Diego	California	United States	92037
2	University of Minnesota	Minneapolis	Minnesota	United States	55455
3	The Ohio State University James Cancer Hospital	Columbus	Ohio	United States	43210
4	Baylor Scott & White Research Institute	Dallas	Texas	United States	75246