NCT03319459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

October 19, 2017

Last Update Submit

November 18, 2021

Conditions

HER2 Positive Gastric CancerColorectal CancerHead and Neck Squamous Cell CarcinomaEGFR Positive Solid TumorAdvanced Solid TumorsHER2-positive Breast CancerHepatocellular CarcinomaNon Small Cell Lung CancerRenal Cell CarcinomaPancreatic CancerMelanoma

Keywords

Solid TumorHER2EGFRAdvanced Solid TumorBreast CancerHead and Neck CancerHead and Neck Squamous Cell CarcinomaColorectal CancerGastric CancerHER2 PositiveEGFR PositiveEGFR+HER2+ImmunotherapyNK cell therapyNatural killer cell therapyantibody-dependent cell-mediated cytotoxicityADCCNon small cell lung cancerRenal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Objective-response rate (ORR)

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

  • 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

Study Arms (3)

Regimen A

EXPERIMENTAL

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

Drug: FATE-NK100

Regimen B

EXPERIMENTAL

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-NK100Drug: Trastuzumab

Regimen C

EXPERIMENTAL

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-NK100Drug: Cetuximab

Interventions

FATE-NK100DRUG

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

Regimen ARegimen BRegimen C
CetuximabDRUG

Epidermal growth factor receptor inhibitor antineoplastic agent

Also known as: Erbitux
Regimen C
TrastuzumabDRUG

HER2/neu receptor inhibitor

Also known as: Herceptin
Regimen B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCSD Moores Cancer Center

San Diego, California, 92037, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

The Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Related 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.

    PMID: 28790065BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsSquamous Cell Carcinoma of Head and NeckCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellPancreatic NeoplasmsMelanomaBreast NeoplasmsHead and Neck NeoplasmsStomach NeoplasmsKidney Neoplasms

Interventions

CetuximabTrastuzumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinomaLiver NeoplasmsLiver DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesBreast DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jeff Chou, MD

    Fate Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 24, 2017

Study Start

January 18, 2018

Primary Completion

May 29, 2020

Study Completion

December 15, 2020

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)