NCT03319459

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	FATE-NK100	FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
DRUG	Cetuximab	Epidermal growth factor receptor inhibitor antineoplastic agent
DRUG	Trastuzumab	HER2/neu receptor inhibitor

Timeline

• Start date: 2018-01-18
• Primary completion: 2020-05-29
• Completion: 2020-12-15
• First posted: 2017-10-24
• Last updated: 2021-11-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study