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

Primary Purpose

HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

FATE-NK100

Cetuximab

Trastuzumab

About this trial

This is an interventional treatment trial for HER2 Positive Gastric Cancer focused on measuring Solid Tumor, HER2, EGFR, Advanced Solid Tumor, Breast Cancer, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Gastric Cancer, HER2 Positive, EGFR Positive, EGFR+, HER2+, Immunotherapy, NK cell therapy, Natural killer cell therapy, antibody-dependent cell-mediated cytotoxicity, ADCC, Non small cell lung cancer, Renal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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.
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.

Sites / Locations

UCSD Moores Cancer Center
University of Minnesota
The Ohio State University James Cancer Hospital
Baylor Scott & White Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Regimen A

Regimen B

Regimen C

Arm Description

FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03319459

First Posted

October 19, 2017

Last Updated

November 18, 2021

Sponsor

Fate Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03319459

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 18, 2018 (Actual)

Primary Completion Date

May 29, 2020 (Actual)

Study Completion Date

December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fate Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Solid Tumor, HER2, EGFR, Advanced Solid Tumor, Breast Cancer, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Gastric Cancer, HER2 Positive, EGFR Positive, EGFR+, HER2+, Immunotherapy, NK cell therapy, Natural killer cell therapy, antibody-dependent cell-mediated cytotoxicity, ADCC, Non small cell lung cancer, Renal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regimen A

Arm Type

Experimental

Arm Description

FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.

Arm Title

Regimen B

Arm Type

Experimental

Arm Description

Arm Title

Regimen C

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

FATE-NK100

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

Epidermal growth factor receptor inhibitor antineoplastic agent

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

HER2/neu receptor inhibitor

Primary Outcome Measure Information:

Title

Incidence of dose-limiting toxicity (DLT)

Description

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).

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Objective-response rate (ORR)

Description

Time Frame

28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.

Title

Pharmacokinetics (PK) of FATE-NK100

Description

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.

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeff Chou, MD

Organizational Affiliation

Fate Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

UCSD Moores Cancer Center

City

San Diego

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

The Ohio State University James Cancer Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Baylor Scott & White Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28790065

Citation

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.

Results Reference

background

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/28790065

Description

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

Learn more about this trial

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

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