NCT06915025 - 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 | Biotech Hunter

Enrollment

500

Participants

Timeline

Start Date

July 9, 2025

Primary Completion Date

October 31, 2032

Study Completion Date

October 31, 2032

Conditions

Epithelial Ovarian CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Interventions

DRUG

IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)

100 mg/m2 IP given weekly during frontline treatment

DRUG

Paclitaxel

175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment

DRUG

Carboplatin

AUC 6 IV given every 21 days for 6 cycles during frontline treatment

DRUG

Olaparib

Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.

DRUG

Niraparib

Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.

Trial Locations (4)

RECRUITING

Erlanger Health, Chattanooga

RECRUITING

Washington University School of Medicine in St. Louis, St Louis

RECRUITING

Providence Cancer Institute, Portland

RECRUITING

Providence Sacred Heart Medical Center & Children's Hospital, Spokane