Phase 1 Ovarian Cancer Trial, Recruiting

Written by an AI model from 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 who have been diagnosed through laboratory testing with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (but not the mucinous type).
• People whose cancer has come back or stopped responding to treatment, and who have already tried at least one standard chemotherapy plan that included a platinum-based drug — with evidence of disease return shown on scans or clinical signs (a rise in CA125 blood marker alone is not considered enough evidence).
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health performance scale (ECOG).
• People who are expected to live for at least 3 more months.
• People who still have side effects from previous treatments that have not fully resolved, as long as those side effects are at a mild level (Grade 1 or below), except for hair loss, skin pigmentation changes, or other effects the trial team considers low risk.
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement rules (RECIST 1.1).
• People with adequate kidney, liver, bone marrow, blood clotting, and immune system function based on blood tests.
• People who test negative for pregnancy within 14 days before starting treatment, and who agree to use at least one approved method of contraception throughout the trial and for at least 6 months after the last dose of the trial drug.
• People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.

Who may not be able to join:

• People with cancer that has spread to the brain or the lining around the brain — though people who have had brain metastases that were treated and have been neurologically stable for 3 or more months may still be considered (confirm with trial site).
• People who have had another type of cancer in the past 3 years, unless it was a type that is considered easily and fully cured locally, such as certain skin cancers, early-stage bladder cancer, or non-invasive cervical or breast cancer.
• People who have had major surgery (Grade II or above) within the past 4 weeks, unless it was a minor procedure performed through a digestive endoscope.
• People who have received radiotherapy within the past 2 weeks (the trial team may consider timing based on how well side effects have recovered).
• People who are currently enrolled in another clinical treatment study, or have been in one within the past 4 weeks.
• People who have received local cancer treatment within the past 4 weeks.
• People who are allergic to the trial drug or any of its ingredients.
• People who have had a severe allergic reaction to a smallpox vaccine in the past.
• People who have had a serious skin condition requiring systemic (whole-body) treatment within the past 2 years, such as severe eczema, atopic dermatitis, burns, psoriasis, or severe acne.
• People who have had a transplant of donated tissue or a solid organ.
• People with an active infection or unexplained fever above 38.5°C.
• People with active tuberculosis (TB) who are currently receiving or have received TB treatment within the past year.
• People who test positive for HIV, Hepatitis C, syphilis, or active Hepatitis B.
• People with a history of serious heart or blood vessel conditions, including:
  • Moderate to severe heart failure (NYHA Class III or above)
  • Serious irregular heartbeat requiring ongoing medication
  • A heart attack, severe chest pain, or heart/artery bypass surgery or stenting within the past 6 months
  • Reduced heart pumping function (ejection fraction below 60%)
  • Certain abnormalities in heart electrical rhythm, or a family history of specific heart rhythm conditions
  • Uncontrolled high blood pressure (systolic above 160 mmHg or diastolic above 100 mmHg)
• People with active autoimmune diseases such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar conditions — though some milder autoimmune conditions (such as well-controlled Type 1 diabetes, hypothyroidism managed with hormone replacement, or skin conditions not needing systemic treatment) may be acceptable (confirm with trial site).
• People with rapidly worsening fluid build-up in the abdomen or lungs that is causing significant symptoms and requires drainage more than once every 14 days.
• People for whom placement of an intraperitoneal (abdominal) catheter would not be safe — for example, due to a blocked or severely distended bowel, a rigid abdomen with widespread tumour growth on the abdominal wall, or an abdominal hernia mesh that prevents safe surgical access.
• People with active bleeding in the digestive tract.
• People with unstable mental health conditions, or active misuse of alcohol or drugs.
• People whom the trial investigators consider unsuitable for the study for any other reason.

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