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

NCT03393884 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Premal H. Thaker, M.D · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2024-07-25
Completion
2026-05-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393884 on ClinicalTrials.gov