A Phase I Study of the Safety and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered In Combination With Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Trial ID #	NCT02480374; OVATION 1
Phase	I
Drug Class	Immunotherapy: Immune Cell Stimulators/IL-12R
Drug Name	IMNN-001
Alternate Drug Names	IMNN-001, PEG-PEI-cholesterol lipopolymer-encased IL-12 DNA plasmid vector GEN-1, EGEN-001, phIL-12-005/PPC, GEN-1
Drugs in Trial	Carboplatin, IMNN-001, Paclitaxel
Eligible Participant	Newly diagnosed stage III/IV ovarian cancer
Patients Enrolled	18
Therapy Setting	First-line
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, evaluated per RECIST
Efficacy	18 patients 14 evaluable: ORR (at IDS): 85.7% (2CR, 10PR) R0 resection rate: 64.3% PFS: 21 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: neutropenia (40%), anemia (27%), leukopenia (17%), thrombocytopenia (17%), nausea ( 13%), fatigue (13%), dehydration (13%), diarrhea (13%)
Conclusion	Adding IMNN-001 (GEN-1) IP to carboplatin+paclitaxel is safe, appears to be active in patients receiving neoadjuvant treatment and impacts the tumor microenvironment
Reference	Thaker PH et al. GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study. Clin Cancer Res (2021) 27(20):5536-5545 https://pubmed.ncbi.nlm.nih.gov/34326131/