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IMNN-001 in Advanced Ovarian Cancer
NCT06915025Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Oct 2032
- Countries
- 1
- Sponsor
- Imunon, Inc.
- Modality
- Gene Editing, Nanoparticles, Gene Silencing
- Drugs
- IMNN-001
- Conditions
- epithelial ovarian cancer (EOC)fallopian tube cancer (PFTC)primary peritoneal carcinoma (PPC)
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Overview
Phase 3, randomised, open-label trial of IMNN-001 in epithelial ovarian cancer (EOC), fallopian tube cancer (PFTC) and primary peritoneal carcinoma (PPC) (2 arms), sponsored by Imunon, Inc. Primary endpoint: Overall Survival at 48 months. Started Jul 2025; status: recruiting.
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Design
2 arms- Study design
- RandomizedOpen-label
Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy
IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy
Control Arm: SOC Chemotherapy + SOC Maintenance Therapy
Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy
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Who it enrols
Female patients >=18 years with newly diagnosed, Stage IIIB/C or IV high-grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer eligible for neoadjuvant chemotherapy.
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Endpoints
Primary
Overall Survival
Secondary
Chemotherapy Response Score
Surgical Response
Time to Second Line Treatment
Objective Response Rate
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