New drug combo aims to wipe out hidden ovarian cancer cells
NCT ID NCT05739981
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 6 times
Summary
This study tests whether adding the experimental drug IMNN-001 to standard chemotherapy and bevacizumab can better eliminate remaining cancer in people with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer. About 30 participants will be randomly assigned to receive either the standard treatment alone or with IMNN-001. The main goal is to see if the combination reduces the amount of cancer found during a second-look surgery.
Why investors are watching
IMUNON is testing its drug IMNN-001 added to standard chemotherapy plus bevacizumab in 30 patients with newly diagnosed advanced ovarian cancer. For a micro-cap company with few products, this randomized Phase I/II readout could determine whether IMNN-001 has a future and whether the company has a lead asset.
If it works: A positive result could show that adding IMNN-001 improves disease control or surgical outcomes, giving IMUNON a credible candidate to advance into later-stage trials. That could attract partners or funding for further development.
If it fails: The trial could fail to show added benefit, or safety issues could emerge, which would likely end IMNN-001's development and leave IMUNON without a clear pipeline. Early-stage trials often fail, so a negative outcome is a real possibility.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology). 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 recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider. 3. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function. 4. 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. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms. 5. 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. 6. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria. 7. Subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and agree to practice an effective form of contraception. If applicable, subjects must discontinue breastfeeding prior to study entry. 8. Subjects must have signed an IRB-approved informed consent. 9. Subjects must be at least 18 years old. Exclusion Criteria: 1. Subjects who have received prior treatment with IMNN-001. 2. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study. 3. Subjects who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid (prednisone equivalent of \> 10 mg/day) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed. 4. Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. 5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded. 6. 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. Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma in-situ, etc. are eligible. 7. Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed more than three years prior to registration, and the subject remains free of recurrent or metastatic disease. 8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the subject remains free of recurrent or metastatic disease. 9. Subjects with known active hepatitis. 10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater). 11. Subjects with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the subject to extreme risk or decreased life expectancy. 12. Subjects with clinically significant cardiovascular disease. 13. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial. 14. 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. 15. Subjects with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary. 16. Subjects having hemoptysis within the last month. 17. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Medicine SKCCC
COMPLETEDBaltimore, Maryland, 21231, United States
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Memorial Sloan Kettering Cancer Center
ACTIVE_NOT_RECRUITINGNew York, New York, 10065, United States
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OU Health, Stephenson Cancer Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer