Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer

Eligible participants will be randomly assigned 1:1 to receive either chemotherapy plus IMNN-001 or chemotherapy alone, followed by standard of care maintenance therapy.

Randomization will stratify by confirmed biomarker tumor homologous recombination deficiency status and stage of cancer.

On both arms, the chemotherapy regimen will consist of paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1 of each cycle. This will be repeated every 3 weeks for a total of 6 cycles, 3 in the neoadjuvant period and 3 in the adjuvant period following interval debulking surgery (IDS). On the experimental arm, IMNN-001 at a dose of 100 mg/m2 will be administered IP on Days 8 and 15 of the first chemotherapy cycle and then on Days 1, 8, and 15 of all subsequent 5 chemotherapy cycles for a total of 17 treatments in the neoadjuvant and adjuvant settings. When given on the same day as chemotherapy, IMNN-001 should be given at least 30 minutes after completion of carboplatin infusion. IDS will take place after 3 cycles of neoadjuvant chemotherapy (NACT) + IMNN-001 for 8 doses. Additional cycles of NACT are allowed at the discretion of the investigator but with discussion with the medical monitor.

An independent Data Monitoring Committee (iDMC) will monitor participants' safety and study conduct throughout the course of the trial.