Clinical trial · Interventional
Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer
A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.
Summary
Brief summary (as posted)
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the human gene for interleukin-12 \[IL-12\] (a cytokine) in a special carrier system designed to enter the cells and help the body produce cytokines. This study has two purposes; the first is to determine what different strengths of EGEN-001 can be given safely without major side effects, and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGEN-001 (phIL-12-005/PPC) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGEN-001
- interventionNames
- Genetic: EGEN-001 (phIL-12-005/PPC)
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer
Secondary outcomes (3)
- measure
- To assess the preliminary efficacy of EGEN-001 by monitoring detectable tumor burden in patients with recurrent epithelial cancer
- measure
- To assess EGEN-001 distribution by measuring human interleukin-12 plasmid (phIL-12) DNA copy number in the blood and peritoneal fluid
- measure
- To assess the biological effects of EGEN-001 on cytokine production by measuring interferon (IFN) gamma and interleukin-12 (IL-12) concentrations in the blood and peritoneal fluid
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Female and at least 19 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation) * Have received previous treatment for ovarian cancer that included a platinum based chemotherapy regimen * Have recurrent epithelial ovarian cancer * Have a measurable tumor by computed tomography (CT) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) * Have an ECOG performance status score of 0, 1, or 2 * If of childbearing potential, agree to follow an acceptable method of birth control (e.g., abstinence, intrauterine device \[IUD\] or barrier method), as determined by the investigator, for the duration of the study. Hormonal contraceptives should not be used as the sole method of birth control. * Have normal organ and marrow function as defined below: * Leukocytes ≥ 3,000/µL; * Absolute neutrophil count ≥ 1,500/µL; * Platelets ≥ 100,000/µL; * Total bilirubin within institutional limits; * SGOT/SGPT ≤ 2.5 X institutional upper limit of normal (ULN); * Creatinine within institutional normal limits; OR creatinine clearance ≥ 60mL/min/1.73m2 for patients with creatinine levels above institutional normal. * Have electrocardiogram (ECG) without clinically significant abnormality, as determined by a qualified cardiologist * Have the capability (caregiver) of performing IP site care while at home Exclusion Criteria: * A serious uncontrolled intercurrent medical illness or disorder including, but not limited to, ongoing or active infection, abdominal surgery, autoimmune disorders, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which would limit compliance with study requirements * Intraabdominal disease \> 5 (five) centimeters in diameter * Previous treatment with whole abdominal irradiation * Intestinal dysfunction or suspected extensive adhesions from prior history or findings at laparoscopy * Intrahepatic disease * Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration * Received investigational agents within three months prior to study drug dosing * Receipt of any medications (in particular, systemic or topical steroids) or substances known to affect, or with the potential to affect, the activity of EGEN-001 * Life expectancy of less than three months * Known human immunodeficiency virus (HIV) infection * Positive HbsAg * Positive hepatitis C virus (HCV) serology * Prior IP drug administration * Prior immunotherapy for ovarian cancer * Chemotherapy within four weeks prior to placement of IP catheter * Radiotherapy within eight weeks prior to placement of IP catheter * Contraindication (either allergy or impaired renal function) to injection with contrast media for adequate evaluation of tumor size by CT scan * Pregnant or breast feeding an infant
References
Publications (0)
Data not yet available