Phase 2 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:

• Adults aged 18 or older who have signed a consent form and are able to follow the study requirements.
• People whose cancer tissue shows HER2 expression, confirmed by local testing.
• People who can provide a stored tumour tissue sample (either a tissue block or at least 20 prepared slides) for research purposes.
• People with a confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, and/or fallopian tube cancer that has come back after previous treatment.
• People with a general health/activity level rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations in physical activity.
• People whose cancer was confirmed by scans to have progressed while receiving a PARP inhibitor as a maintenance treatment (either first- or second-line), with that progression documented within 180 days of their last PARP inhibitor dose, and who received at least 6 months of that PARP inhibitor treatment without progression during that time.
• People whose disease can be measured on scans according to standard research criteria (RECIST 1.1).
• People whose heart pumping function (LVEF) is 50% or above, measured within 28 days before joining the trial.
• People whose blood counts, kidney function, liver function, and blood clotting levels fall within acceptable ranges as defined by the trial (confirm specific values with the trial site).
• People who have a negative pregnancy blood test within 72 hours before the first study treatment dose, or who are confirmed to be past childbearing age or have had a relevant surgical procedure, supported by medical records.
• People of childbearing potential who agree to use a highly effective form of contraception from the time of consent until 150 days after the last study treatment dose.
• People with low levels of protein in their urine (less than 2+ on a urine test, or if 2+ or higher, a 24-hour urine collection showing less than 1 gram of protein).

Who may not be able to join:

• People whose cancer did not respond to platinum-based chemotherapy at all, or whose cancer came back within 6 months of their last platinum treatment in the second-line setting.
• People who have had another cancer diagnosis within the past 3 years, with some exceptions for certain low-risk skin cancers or cancers considered cured (confirm with trial site).
• People who have received any cancer treatment (chemotherapy, targeted therapy, hormonal therapy, or radiotherapy) within 21 days before the study start date, or within a shorter period depending on how long the most recent treatment stays in the body.
• People with uncontrolled cancer that has spread to the brain or the lining around the brain and spinal cord.
• People with an active and uncontrolled infection — though people with well-managed HIV, chronic hepatitis B, or treated hepatitis C may be eligible if specific conditions are met (confirm with trial site).
• People who have not yet recovered from side effects of previous cancer treatment (with some exceptions for low-grade nerve damage, hair loss, or tiredness).
• People who have not fully recovered from a major surgical procedure before starting the study.
• People with a known allergy or sensitivity to the study drugs or their ingredients.
• People with an active or ongoing bowel blockage.
• People who have had lung inflammation (interstitial lung disease or pneumonitis) requiring steroid treatment, currently have this condition, or where it cannot be ruled out on scans.
• People with significant or uncontrolled heart conditions, including certain abnormal heart rhythms, heart attack within the past 6 months, uncontrolled chest pain within the past 6 months, moderate-to-severe heart failure, uncontrolled high blood pressure, certain electrical conduction problems in the heart, or certain abnormal troponin (a heart marker) levels with symptoms (confirm details with trial site).
• People currently taking part in another clinical trial or who have received an experimental treatment within 4 weeks of the planned first study dose.
• People with significant bleeding disorders or blood clotting problems (not caused by intentional anticoagulation therapy).
• People with an active fistula (an abnormal connection or passage) in the abdomen or pelvis.
• People with serious uncontrolled medical conditions, psychiatric conditions, or substance use disorders that would affect their ability to safely participate in the trial.
• People who have previously been treated with certain HER2-targeted therapies or a specific type of antibody-drug treatment that targets a particular enzyme (confirm details with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 7 months after the last dose.
• People who have received a live vaccine within 30 days before the first study dose (inactivated vaccines are generally permitted — confirm with trial site).

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