Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
NK-101
- NCT ID:
NCT03319459
Conditions
- 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
Interventions
Drug | Synonyms | Arms |
---|
FATE-NK100 | | Regimen A |
Cetuximab | Erbitux | Regimen C |
Trastuzumab | Herceptin | Regimen B |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Regimen A | Experimental | FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. | |
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. | |
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. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicity (DLT) |
Time Frame: | 28 days |
Safety Issue: | |
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). |
Secondary Outcome Measures
Measure: | Objective-response rate (ORR) |
Time Frame: | 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days. |
Safety Issue: | |
Description: | 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. |
Measure: | Pharmacokinetics (PK) of FATE-NK100 |
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 |
Safety Issue: | |
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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Fate Therapeutics |
Trial 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
Last Updated
January 9, 2020