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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 10, 2023

Primary Completion Date

August 30, 2026

Study Completion Date

January 30, 2028

Conditions
Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
Interventions
DRUG

Paclitaxel

Paclitaxel 175 mg/m2 IV

DRUG

Carboplatin

Carboplatin AUC 5-6 IV

DRUG

Bevacizumab

BEV 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.

DRUG

IMNN-001

IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer

Trial Locations (4)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

21231

RECRUITING

Johns Hopkins Medicine SKCCC, Baltimore

73104

RECRUITING

OU Health, Stephenson Cancer Center, Oklahoma City

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Breakthrough Cancer Research

UNKNOWN

lead

Imunon

INDUSTRY

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 | Biotech Hunter | Biotech Hunter