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

Phase 1

Completed

• Conditions: HER2-positive Breast Cancer; Head and Neck Squamous Cell Carcinoma; Melanoma; HER2 Positive Gastric Cancer; Colorectal Cancer; EGFR Positive Solid Tumor; Advanced Solid Tumors; Hepatocellular Carcinoma; Non Small Cell Lung Cancer; Renal Cell Carcinoma
• Interventions: Drug: FATE-NK100; Drug: Trastuzumab; Drug: Cetuximab

• Registration Number: NCT03319459
• Lead Sponsor: Fate Therapeutics

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-24
• Study Start: 2018-01-18
• Primary Completion: 2020-05-29
• Study Completion: 2020-12-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen B	FATE-NK100	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	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.
Regimen A	FATE-NK100	FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
Regimen B	Trastuzumab	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	Cetuximab	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.

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicity (DLT)	28 days	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

Name	Time	Method
Objective-response rate (ORR)	28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.	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.
Pharmacokinetics (PK) of FATE-NK100	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	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.

Trial Locations

Locations (4)

UCSD Moores Cancer Center; 🇺🇸 San Diego, California, United States

The Ohio State University James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States