Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with ovarian, fallopian tube, or primary peritoneal cancer with a specific type called high-grade serous adenocarcinoma (including poorly differentiated carcinomas consistent with this type), confirmed through tissue biopsy or surgery (not fluid samples alone)
• People whose cancer has been classified as Stage III or IV, and whose cancer specialist has recommended chemotherapy before surgery (called neoadjuvant therapy)
• People whose bone marrow, kidneys, liver, and nervous system are functioning well enough to meet the trial's health requirements
• People who have been free of active infections needing isolation or intravenous antibiotics for at least four weeks before joining, and if previously diagnosed with COVID-19, at least 14 days have passed since a positive test or the start of symptoms
• People who have stopped any hormone therapy aimed at treating their cancer at least one week before the first treatment (hormone replacement therapy for other reasons may continue)
• People with a physical performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physically strenuous activity
• People of childbearing potential who have had a negative blood pregnancy test within 14 days before starting treatment, and who agree to use effective contraception during the trial
• People who have stopped breastfeeding before entering the study (if applicable)
• People who have read and signed the trial's informed consent form approved by an ethics review board
• People aged 18 or older

Who may not be able to join:

• People who have previously been treated with the study drug IMNN-001
• People who have had a significant allergic reaction to drugs with a similar chemical or biological makeup to IMNN-001 or other drugs used in this trial
• People who have taken steroid medications (by mouth or injection) within 2 weeks before the first dose of IMNN-001, or who require ongoing immune-suppressing steroid treatment at doses greater than 10 mg of prednisone (or equivalent) per day for reasons unrelated to chemotherapy (steroid use to prevent reactions to contrast dye used in scans is allowed)
• People who have an autoimmune disease — such as lupus, multiple sclerosis, inflammatory bowel disease, or rheumatoid arthritis — that has required immune-suppressing treatment within the last 2 years
• People known to have HIV or HTLV infections
• People with another serious (invasive) cancer that has been present or active within the last three years, or whose previous cancer treatment would conflict with this trial (non-invasive skin cancers and melanoma in-situ are generally not excluded)
• People who have previously had radiation therapy to the abdomen or pelvis (prior radiation to the breast, head and neck, or skin may be acceptable if it was completed more than three years ago and the cancer has not returned)
• People who have previously received chemotherapy for any cancer in the abdomen or pelvis (prior chemotherapy for early breast cancer may be acceptable if completed more than three years ago and the cancer has not returned)
• People with a known active hepatitis infection
• People with a kidney condition causing significant protein loss in the urine (nephrotic syndrome, Grade 2 or higher) (confirm with trial site)
• People with serious ongoing medical problems unrelated to their cancer that could make it unsafe or difficult to fully participate in the trial
• People with significant heart or blood vessel disease
• People of childbearing potential who are not using adequate contraception, who are currently pregnant, or who are breastfeeding
• People with a history of brain tumours, uncontrolled seizures, cancer spread to the brain, or a stroke, mini-stroke, or brain bleed within six months before starting treatment
• People who have had diverticulitis (an infection of the bowel wall) within the past 6 months (having diverticulosis, a milder related condition, is not excluded)
• People who have coughed up blood in the last month
• People with any physical condition that would prevent the safe placement of the tube used to deliver the study drug into the abdomen — including abdominal surgery within 4 weeks of joining (for reasons other than placing the drug delivery port), bowel problems, abnormal connections between organs, or likely extensive internal scarring identified through history or diagnostic laparoscopy

Important: Always verify eligibility with the trial site directly before applying.