Phase 3 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 are able to understand and sign a written consent form agreeing to take part in the trial
• Women aged 18 or older
• People with a life expectancy of at least 12 weeks
• People with a general health and activity level rated as 0 or 1 on a standard cancer performance scale (meaning fully active or able to carry out light work)
• People with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has been confirmed by tissue or cell testing, and that has either spread to other parts of the body or cannot be surgically removed
• People whose cancer has been confirmed to have continued growing or spreading during or after their most recent cancer treatment
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement guidelines
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%, tested within 28 days before the first dose
• People with adequate bone marrow and organ function (as determined by the trial site)
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and must use effective contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People whose cancer is of certain specific types, including endometrioid, clear cell, mucinous, or mesenchymal tumours, or low-grade or borderline tumours, or any cancer containing these components
• People currently taking part in another interventional clinical trial (observational studies are generally acceptable — confirm with trial site)
• People whose cancer has already been treated with and progressed on all four chemotherapy drugs used in the trial's comparison group (paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan), or who are ineligible for all of them
• People who have received intravenous chemotherapy, large-molecule targeted therapy, immunotherapy, chemotherapy into the abdomen, or tumour embolisation within the past 4 weeks
• People who have taken oral chemotherapy, small-molecule targeted drugs, hormone-based cancer therapy, or certain herbal medicines for cancer within the past 2 weeks or 5 half-lives of the drug (whichever is longer)
• People who have had intensive (radical) radiotherapy within the past 4 weeks, or palliative radiotherapy within the past 2 weeks
• People who have taken strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers) within the past 2 weeks or 5 half-lives (whichever is longer)
• People who have had major surgery within the past 4 weeks, or keyhole (laparoscopic) surgery within the past 2 weeks, or who have wounds, injuries, or ulcers that have not healed
• People who have received a live vaccine within the past 4 weeks (note: mRNA vaccines and certain adenovirus-based vaccines are not considered live vaccines — confirm with trial site)
• People who still have side effects from previous cancer treatments that have not resolved to a mild or absent level
• People with cancer that has spread to the brain or spinal cord and is causing symptoms, or a history of cancer involving the membranes around the brain or spinal cord
• People with lung inflammation (pneumonitis) that requires steroid treatment, or a history of other significant lung disease
• People with uncontrolled or serious heart or blood vessel conditions
• People who have used immune-suppressing medications within the 14 days before the first dose
• People whose tumour has grown into surrounding important tissues or organs
• People who have had a significant bleeding episode within the past 3 months
• People with fluid build-up in the abdomen or pelvis that is causing symptoms and requires drainage or other treatment
• People with varicose veins in the oesophagus or stomach that are at high risk of bleeding or need immediate treatment, or people with signs of increased pressure in the liver's blood supply system (portal hypertension)
• People with an unhealed blockage, perforation, or abnormal opening (fistula) in the digestive tract, or who are at risk of developing one
• People who have a stent (tube) placed inside the digestive tract or windpipe
• People with a blockage of the bile ducts
• People with serious liver conditions, including a specific type of brain complication from liver disease (hepatic encephalopathy), a combined kidney-liver failure condition (hepatorenal syndrome), or significant liver scarring (cirrhosis rated Child-Pugh class B or worse)
• People with significant malnutrition
• People with an active infection that is not under control
• People who have had another separate cancer in the past 3 years, or have any other cancer that is active or at risk of returning
• People with a history of immune system deficiency, whether present from birth or developed over time
• People who have had an organ transplant from a donor, a bone marrow transplant from a donor, or a stem cell transplant using their own cells
• People with a known allergy to other anti-HER2 antibody treatments or any ingredient in the study drug (IBI354)
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with other health conditions, abnormal test results, or mental health, neurological, or social circumstances that the trial site determines make participation unsuitable or unsafe

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