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.
Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology).
Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider.
Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.
Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms.
Subjects who have received prior treatment with IMNN-001.
Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study.
Subjects who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid (prednisone equivalent of > 10 mg/day) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed.
Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
Parallel
Paclitaxel
DrugPaclitaxel 175 mg/m2 IV
Carboplatin
DrugCarboplatin AUC 5-6 IV
Bevacizumab
DrugBEV 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.
IMNN-001
DrugIL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
Minimal Residual Disease
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).
PFS
Progression Free Survival comparison in experimental vs. control arm
OS
Overall Survival comparison in experimental vs. control arm
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Imunon
Lead sponsor
Breakthrough Cancer Research
Collaborator
