CompletedPhase 1NCT03319459

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

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.

Checked against the public recordLast updated Nov 22, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations4
SponsorFate Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Fate Therapeutics
Interventions being studied
Drug: FATE-NK100; Drug: Cetuximab; Drug: Trastuzumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCSD Moores Cancer CenterSan Diego, California
  • University of MinnesotaMinneapolis, Minnesota
  • The Ohio State University James Cancer HospitalColumbus, Ohio
  • Baylor Scott & White Research InstituteDallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 22, 2021. Always confirm current availability with the study team.

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