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.
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
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Amir Jazaeri, MD · STUDY_CHAIR · University of Texas MD Anderson Center
Who to contact
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What this trial measures
- 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).