NCT03393884

Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Imunon · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IMNN-001	IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
DRUG	Carboplatin	AUC 6 IV over 1 hour on Day 1 of each cycle
DRUG	Paclitaxel	175 mg/m2 IV over 3 hours on Day 1 of each cycle

Timeline

• Start date: 2018-09-05
• Primary completion: 2024-07-25
• Completion: 2026-04-30
• First posted: 2018-01-09
• Last updated: 2026-04-13

Locations

21 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study