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