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

Last updated: August 12, 2025
Sponsor: Imunon
Overall Status: Active - Recruiting

Phase

3

Condition

Fallopian Tube Cancer

Ovarian Cancer

Pelvic Cancer

Treatment

Carboplatin

Paclitaxel

Niraparib

Clinical Study ID

NCT06915025
201-24-301
  • Ages > 18
  • Female

Study Summary

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be female, ≥18 years of age, able to understand the studyprocedures, and agree to participate in the study by providing written informedconsent.

  2. Participants with a histologically confirmed diagnosis of high-grade non-mucinousepithelial ovarian (serous, endometrioid, carcinosarcoma, mixed epithelialpathologies), fallopian tube or peritoneal cancer that is Stage IIIB/C or IVaccording to the International Federation of Gynecology and Obstetrics (FIGO) ortumor, node and metastasis staging criteria.

  3. Participants eligible to receive neoadjuvant chemotherapy.

  4. Participants will provide a tumor tissue sample at pre-screening or screening, vialaparoscopy or image guided core biopsy for determination of confirmed biomarkertumor status (HRD vs. HRP). See biomarker status definitions in the section below.

  5. Participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) within 14 days prior to initiation of protocoltherapy and be practicing an effective form of contraception. If applicable,participants must discontinue breastfeeding prior to study entry.

  6. Participants must have adequate:

  7. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µl. Exceptions may be made in patients with benign ethnic neutropenia >800/ul with approval of a medical monitor. This ANC cannot have been inducedor supported by granulocyte colony stimulating factors. Platelets greater thanor equal to 100,000/µl.

  8. Renal function: eGFR > 60 ml/min/1.73m2

  9. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULNand alkaline phosphatase ≤ 2.5 x ULN. Exceptions due to hepatic metastases canbe considered in consultation with medical monitor.

  10. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1 as defined by CTCAE version 5.0.

  11. Participants must have an ECOG score of 0, 1 or 2.

  12. Participants should be free of active infection requiring parenteral antibiotics ora serious uncontrolled medical illness or disorder within 4 weeks of study entry.

  13. Any hormonal therapy directed at the malignant tumor must be discontinued at leastone week prior to the first treatment. Continuation of hormone replacement therapyis permitted.

Exclusion

Exclusion Criteria:

  1. Participant who has received prior treatment with IMNN-001.

  2. Participant who has received oral or parenteral corticosteroids (>10 mg prednisone)within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinicalrequirement for ongoing systemic immunosuppressive therapy such as chronic steroiduse not related to chemotherapy administration.

  3. Participant has mucinous, germ cell, transitional cell, clear cell,undifferentiated, or non-epithelial ovarian cancer.

  4. Participant has low-grade or Grade 1 epithelial ovarian cancer.

  5. Participant of childbearing potential, not practicing adequate contraception,participant who is pregnant, or participant who is breastfeeding are not eligiblefor this trial.

  6. Participant has a bowel obstruction by clinical symptoms or computed tomography (CT)scan, sub-occlusive mesenteric disease, abdominal or gastrointestinal fistula,gastrointestinal perforation, or intra-abdominal abscess.

  7. Participant has been diagnosed and/or treated with any therapy for invasive cancer <3 years from study enrollment, completed adjuvant chemotherapy and/or targetedtherapy at least 3 years from enrollment, or completed adjuvant hormonal therapyless than 4 weeks from enrollment.

  8. Participant with definitively treated non-invasive malignancies such as cervicalcarcinoma in situ, ductal carcinoma in situ, grade 1 or 2 Stage IA endometrioidendometrial cancer, or non-melanomatous skin cancer are allowed.

  9. Participant with concurrent severe medical problems unrelated to the malignancy thatwould significantly limit full compliance with the study or expose the participantto extreme risk or decreased life expectancy.

  10. Participant has known active hepatitis or HIV with detectable viral load.

  11. Participant has a known contraindication or uncontrolled hypersensitivity to thecomponents of paclitaxel, carboplatin, IMNN-001, or their excipients.

  12. Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, orperitoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiationtherapy).

  13. Participant is receiving treatment for active autoimmune disease. "Active" refers toany condition currently requiring therapy. Examples of autoimmune disease includesystemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease andrheumatoid arthritis.

  14. Participant who has received prior radiotherapy to any portion of the abdominalcavity or pelvis is excluded. Prior radiation for localized cancer of the breast,head and neck, or skin is permitted, if it was completed at least 3 years prior toregistration, and the participant remains free of recurrent or metastatic disease.

  15. Participant who has received prior chemotherapy for any abdominal or pelvic tumor isexcluded. Participant may have received prior adjuvant chemotherapy for localizedbreast cancer, if it was completed at least three years prior to registration, andthat the participant remains free of recurrent or metastatic disease.

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

  17. Participant who will receive bevacizumab with the neoadjuvant or adjuvant treatment,or as maintenance will be excluded.

  18. Participant with any condition/anomaly that would interfere with the appropriateplacement of the IP catheter for study drug administration including abdominalsurgery within 4 weeks of study entry (for reason other than IP port placement orlaparoscopic diagnosis of epithelial ovarian cancer), intestinal dysfunction asdefined in #6 above.

Study Design

Total Participants: 500
Treatment Group(s): 5
Primary Treatment: Carboplatin
Phase: 3
Study Start date:
July 09, 2025
Estimated Completion Date:
October 31, 2032

Study Description

Eligible participants will be randomly assigned 1:1 to receive either chemotherapy plus IMNN-001 or chemotherapy alone, followed by standard of care maintenance therapy.

Randomization will stratify by confirmed biomarker tumor homologous recombination deficiency status and stage of cancer.

On both arms, the chemotherapy regimen will consist of paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1 of each cycle. This will be repeated every 3 weeks for a total of 6 cycles, 3 in the neoadjuvant period and 3 in the adjuvant period following interval debulking surgery (IDS). On the experimental arm, IMNN-001 at a dose of 100 mg/m2 will be administered IP on Days 8 and 15 of the first chemotherapy cycle and then on Days 1, 8, and 15 of all subsequent 5 chemotherapy cycles for a total of 17 treatments in the neoadjuvant and adjuvant settings. When given on the same day as chemotherapy, IMNN-001 should be given at least 30 minutes after completion of carboplatin infusion. IDS will take place after 3 cycles of neoadjuvant chemotherapy (NACT) + IMNN-001 for 8 doses. Additional cycles of NACT are allowed at the discretion of the investigator but with discussion with the medical monitor.

An independent Data Monitoring Committee (iDMC) will monitor participants' safety and study conduct throughout the course of the trial.

Connect with a study center

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Erlanger Health

    Chattanooga, Tennessee 37403
    United States

    Active - Recruiting

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington 99204
    United States

    Active - Recruiting

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