NCT05739981

Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Imunon · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.

Detailed description

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone. The chemotherapy (NACT \& adjuvant) will be a standard regimen of carboplatin + paclitaxel administered every three weeks for a total of 7-9 cycles. The protocol requires at least 4 cycles of NACT and allows up to 2 additional cycles of neoadjuvant therapy at the Investigator's discretion based on response and other clinical considerations. ICS will take place 3-4 weeks from last dose of NACT. Following at least a 4-week recovery from ICS, 3 additional adjuvant cycles of study treatments will be administered. The minimum time interval between surgery and BEV administration will be 4 weeks for safety. BEV will be included at Cycles 2, 3, 6, and 7. BEV may be substituted by an FDA approved biosimilar. The experimental arm will add IMNN-001 weekly to each cycle of chemotherapy + BEV beginning with Cycle 1 Day 15 and continue weekly through the last cycle of adjuvant therapy.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 175 mg/m2 IV
DRUG	Carboplatin	Carboplatin AUC 5-6 IV
DRUG	Bevacizumab	BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV.
DRUG	IMNN-001	IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer

Timeline

• Start date: 2023-02-10
• Primary completion: 2026-12-30
• Completion: 2028-08-30
• First posted: 2023-02-22
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study