A Phase II Study Evaluating the Effect of GEN-1 on SLL When Administered in Combination With Bevacizumab and NACT in Subjects Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Status: Recruiting
• Trial end date: 2028-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

This is a 1:1 randomized, open label, multi-center phase II trial to evaluate the safety, dosing, efficacy, and biological activity of adding GEN-1 to chemotherapy + BEV compared to chemotherapy + BEV alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imunon
• Collaborator: Break Through Cancer Foundation
• Treatments: Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Subjects must have a suspected diagnosis of high grade epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with histologic confirmation per pre- treatment biopsies.

2. Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been determined to benefit from neoadjuvant therapy.

3. Subjects only with high grade serous adenocarcinoma histologic epithelial cell type are eligible.

4. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.

5. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.

6. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.

7. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.

8. Subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception.

9. Subjects must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.

10. Subjects must have signed an IRB-approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

1. Subjects who have received prior treatment with GEN-1 or who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other drugs used in this study.

2. Subjects who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.

3. Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2 years.

4. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.

5. Subjects with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol therapy.

6. Subjects who have received prior radiotherapy or chemotherapy to any portion of the abdominal cavity or pelvis are excluded.

7. Subjects with known active hepatitis.

8. Subjects with nephrotic syndrome.

9. Subjects with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient subject to extreme risk or decreased life expectancy.

10. Subjects with clinically significant cardiovascular disease.

11. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial.

12. Subjects with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.

13. Subjects with a history of diverticulitis.

14. Subjects having hemoptysis within the last month.

15. Subjects with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, fistulas, or suspected extensive adhesions from prior history or finding at laparoscopy.