Phase 1/2 Study of IMNN-001 for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This study is testing a new treatment called IMNN-001 (an IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) for newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers want to see if adding IMNN-001 to standard chemotherapy (Paclitaxel and Carboplatin) and Bevacizumab (BEV) is safe and effective. You may be eligible if you are a woman aged 18 or older with high-grade serous adenocarcinoma. The main goal is to measure how much cancer remains (Minimal Residual Disease) after 8 months. The study is currently recruiting about 30 participants, but its exact status is unclear.

Study design
This is a Phase 1/2, randomized, open-label study involving multiple centers. About 30 participants will be randomly assigned to receive either the standard chemotherapy plus Bevacizumab, or the standard treatment plus IMNN-001.
What's involved
You will receive chemotherapy and Bevacizumab every three weeks for 7-9 cycles, with IMNN-001 added weekly in the experimental arm. This includes at least 4 cycles before surgery and 3 cycles after surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Minimal Residual Disease, is measured at 8 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Imunon
~30 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinBevacizumabIMNN-001

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal Residual Disease
Measured over 8 months
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
4 sites across 4 states
Maryland1
New York1
Oklahoma1
Texas1
  • Amir Jazaeri, MD · STUDY_CHAIR · University of Texas MD Anderson Center

Opens a ready-to-send draft in your own email app — review before sending.

  • Minimal Residual Disease8 months

    To determine if the addition of IMNN-001 reduces the rate of histologically documented MRD as determined by SLL in the experimental group (chemotherapy + BEV + IMNN-001) as compared to the control group (chemotherapy + BEV).