GEN-1 + NACT for Ovarian Cancer

(OVATION 2 Trial)

Not currently recruiting at 26 trial locations

Overseen By Beth J Llewellyn

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Celsion

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune disease, Other malignancies, Hepatitis, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GEN-1 for ovarian cancer. Researchers aim to determine if combining GEN-1 with standard chemotherapy (NACT) is safer and more effective than chemotherapy alone. Individuals diagnosed with certain types of ovarian, fallopian tube, or peritoneal cancer, who have not received prior treatments like chemotherapy or radiation in the abdomen, might be suitable candidates. The goal is to see if this combination can improve treatment outcomes for those with advanced stages of these cancers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

The trial requires that any hormonal therapy directed at the malignant tumor be stopped at least one week before the first treatment. However, hormone replacement therapy can continue. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IMNN-001, also known as GEN-1, has been safe in earlier studies. The OVATION-2 study, in particular, found that this treatment was safe and well-tolerated. Patients in this study lived longer, especially those with certain genetic traits. Other studies confirm that GEN-1 is generally safe to use with chemotherapy. No unexpected severe side effects have been reported. This makes GEN-1 a promising option for those considering joining a trial for ovarian cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about GEN-1 for ovarian cancer because it introduces a novel approach by combining gene therapy with standard chemotherapy. Unlike traditional treatments like surgery and chemotherapy, GEN-1 uses an active ingredient called IMNN-001, delivered intraperitoneally, to enhance the immune response against cancer cells. This innovative mechanism may boost the effectiveness of chemotherapy and improve patient outcomes by targeting cancer more directly and potentially reducing side effects.

What evidence suggests that GEN-1 might be an effective treatment for ovarian cancer?

Research has shown that GEN-1, also known as IMNN-001, may help treat advanced ovarian cancer. In this trial, one group of participants will receive the standard NACT regimen alone, while another group will receive NACT combined with IMNN-001. A study found that patients who received IMNN-001 lived about 13 months longer and had 3 more months without cancer progression compared to those who had standard treatments. The treatment also appears to enhance the tumor environment's ability to help the body fight cancer. Safety results have been acceptable, particularly for some patients with specific genetic backgrounds. These findings suggest that GEN-1 could be a valuable addition to standard chemotherapy for ovarian cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Premal H. Thaker, M.D

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with ovarian, fallopian tube, or peritoneal cancer who haven't had prior treatments with IMNN-001 or chemotherapy/radiotherapy to the abdomen. They must have good organ function and performance status (able to carry out daily activities), not be pregnant or breastfeeding, and use effective contraception.

Inclusion Criteria

My cancer is one of the specified types of epithelial cell cancer.

I stopped any cancer-related hormone therapy at least a week ago.

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

Exclusion Criteria

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

You have any condition that would make it difficult to place the catheter for giving the study drug.

I have a history or signs of brain or spinal cord disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NACT regimen with or without IMNN-001. NACT involves paclitaxel and carboplatin administered every 3 weeks for 6 cycles. IMNN-001 is administered intraperitoneally on specific days of each cycle.

18 weeks

6 cycles with multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 months

Long-term follow-up

Participants are monitored for overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• GEN-1

Trial Overview The study tests the safety and effectiveness of a new treatment called IMNN-001 when given through the abdomen along with standard chemotherapy (NACT) versus NACT alone in patients with advanced-stage ovarian-type cancers.

How Is the Trial Designed?

Group I: NACT + IMNN-001 Experimental Treatment 3 Interventions

The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.

Group II: NACT Alone Active Control 2 Interventions

The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.

Who Is Running the Clinical Trial?

Celsion

Lead Sponsor

Trials

14

Recruited

1,500+

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+

Citations

1. investors.imunon.com investors.imunon.com/news-releases/news-release-details/imunon-presents-imnn-001-phase-2-translational-data-advanced

IMUNON Presents IMNN-001 Phase 2 Translational Data in ... Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care ...

2. targetedonc.com targetedonc.com/view/imnn-001-continues-to-show-favorable-responses-in-ovarian-cancer

IMNN-001 Continues to Show Favorable Responses in ... IMNN-001 shows promising results in enhancing the tumor microenvironment and improving survival rates in advanced ovarian cancer treatment.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5516

Updated survival analysis from OVATION-2 trial. IMNN-001 demonstrated trends towards material improvement in overall survival and acceptable safety in advanced EOC, especially in HRD+ patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06915025

Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 ... This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to ...

5. onclive.com onclive.com/view/ovation-3-trial-of-imnn-001-seeks-to-confirm-feasibility-of-targeting-il-12-to-boost-immune-responses-in-ovarian-cancer

OVATION-3 Trial of IMNN-001 Seeks to Confirm Feasibility ... Initial early-phase data with IMNN-001 previously demonstrated a favorable safety profile and initial signals of efficacy when administered ...

6. investors.imunon.com investors.imunon.com/news-releases/news-release-details/imunon-presents-positive-phase-2-translational-data-imnn-001

IMUNON Presents Positive Phase 2 Translational Data of ... ASCO 2025 overall survival data bolster IMNN-001's potential in advanced ovarian cancer, supported by robust translational results at ESMO.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0090825825007978

OVATION-2: A randomized phase I/II study evaluating the ... In summary, IMNN-001 treatment in OVATION-2 was safe, yielded clinically meaningful survival benefits in the ITT population and demonstrated IP delivery of the ...