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

Fate Therapeutics

Status and phase: Completed; Phase 1

Conditions: Melanoma; Advanced Solid Tumors; Hepatocellular Carcinoma; HER2-positive Breast Cancer; Non Small Cell Lung Cancer; Renal Cell Carcinoma; EGFR Positive Solid Tumor; HER2 Positive Gastric Cancer; Pancreatic Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Cancer

Treatments: Drug: FATE-NK100; Drug: Trastuzumab; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03319459

NK-101

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

Regimen A

Experimental group

Description:

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

Treatment:

Drug: FATE-NK100

Regimen B

Experimental group

Description:

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.

Treatment:

Drug: Trastuzumab

Drug: FATE-NK100

Regimen C

Experimental group

Description:

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.

Treatment:

Drug: Cetuximab

Drug: FATE-NK100