MedDataX Logo

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

NCT ID: NCT03319459

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regimen A

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

Group Type EXPERIMENTAL

FATE-NK100

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

FATE-NK100

Intervention Type DRUG

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

Trastuzumab

Intervention Type DRUG

HER2/neu receptor inhibitor

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.

Group Type EXPERIMENTAL

FATE-NK100

Intervention Type DRUG

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

Cetuximab

Intervention Type DRUG

Epidermal growth factor receptor inhibitor antineoplastic agent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FATE-NK100

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

Intervention Type DRUG

Cetuximab

Epidermal growth factor receptor inhibitor antineoplastic agent

Intervention Type DRUG

Trastuzumab

HER2/neu receptor inhibitor

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Erbitux Herceptin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fate Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff Chou, MD

Role: STUDY_DIRECTOR

Fate Therapeutics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCSD Moores Cancer Center

San Diego, California, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Site Status

Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28790065 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

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

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NK-101

Identifier Type: -

Identifier Source: org_study_id