A Phase I Study of the Safety and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered In Combination With Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Trial ID # NCT02480374; OVATION 1
Phase I
Drug Class Immunotherapy: Immune Cell Stimulators/IL-12R
Drug Name GEN-1
Alternate Drug Names PEG-PEI-cholesterol lipopolymer-encased IL-12 DNA plasmid vector GEN-1, EGEN-001, phIL-12-005/PPC
Drugs in Trial Carboplatin, GEN-1, Paclitaxel
Eligible Participant

Newly diagnosed stage III/IV ovarian cancer

Patients Enrolled

18

Therapy Setting

First-line

Study Design

Open-Label, Non-randomized

Endpoints

ORR, PFS, evaluated per RECIST

Efficacy

18 patients
14 evaluable: ORR (at interval debulking surgery): 85.7% (2CR, 10PR)
R0 resection rate: 64.3%
PFS: 21 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: neutropenia (40%), anemia (27%), leukopenia (17%), thrombocytopenia (17%), nausea ( 13%), fatigue (13%), dehydration (13%), diarrhea (13%)

Conclusion

Adding GEN-1 IP to carboplatin+paclitaxel is safe, appears to be active in patients receiving neoadjuvant treatment and impacts the tumor microenvironment

Reference

Thaker PH et al. GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study. Clin Cancer Res (2021)
https://pubmed.ncbi.nlm.nih.gov/34326131/

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