Status:
COMPLETED
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
Lead Sponsor:
Fate Therapeutics
Conditions:
HER2 Positive Gastric Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 monothe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03319459
Start Date
January 18 2018
End Date
December 15 2020
Last Update
November 22 2021
Active Locations (4)
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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