Actively Recruiting
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Led by Imunon · Updated on 2026-05-04
30
Participants Needed
4
Research Sites
289 weeks
Total Duration
On this page
Sponsors
I
Imunon
Lead Sponsor
B
Breakthrough Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.
CONDITIONS
Official Title
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma or poorly differentiated carcinomas consistent with high grade serous histology
- FIGO stage III or IV recommended for neoadjuvant therapy by oncology provider
- Adequate bone marrow, kidney, liver, and neurologic function
- No active infection needing isolation or serious uncontrolled illness within 4 weeks prior to study entry
- Discontinued hormonal therapy directed at tumor at least 1 week before first treatment; hormone replacement therapy allowed
- ECOG performance status score of 0-1
- Negative pregnancy test within 14 days before starting treatment and agreement to use effective contraception if of childbearing potential
- Discontinued breastfeeding before study entry if applicable
- Signed informed consent
- At least 18 years old
You will not qualify if you...
- Prior treatment with IMNN-001
- History of allergic reactions to IMNN-001 or similar drugs
- Use of oral or parenteral corticosteroids within 2 weeks before first IMNN-001 dose or need for ongoing systemic immunosuppressive therapy (except for certain steroid prophylaxis)
- Autoimmune disease requiring immunosuppressive therapy within last 2 years
- Known HIV or HTLV infections
- Other invasive malignancies present within last 3 years or prior cancer treatments contraindicating this study
- Prior radiotherapy to abdomen or pelvis (except certain prior localized radiation completed over 3 years ago)
- Prior chemotherapy for abdominal or pelvic tumors
- Known active hepatitis
- Nephrotic syndrome Grade 2 or higher
- Severe medical problems limiting compliance or increasing risk
- Clinically significant cardiovascular disease
- Childbearing potential without adequate contraception, pregnancy, or breastfeeding
- History or evidence of CNS disease including brain tumors, uncontrolled seizures, brain metastases, or recent stroke/TIA
- History of diverticulitis within past 6 months
- Hemoptysis within last month
- Conditions interfering with placement of intraperitoneal catheter including recent abdominal surgery (except IP port placement), intestinal dysfunction, fistulas, or extensive adhesions from prior history or laparoscopy
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Johns Hopkins Medicine SKCCC
Baltimore, Maryland, United States, 21231
Completed
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
3
OU Health, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Douglas Faller, MD
CONTACT
L
Lauren Musso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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