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 who are willing to sign a consent form and follow the study's requirements
• People aged 18 to 75 years
• People with a life expectancy of at least 3 months
• People who have a confirmed diagnosis (through lab testing of tissue or cells) of recurrent or metastatic gynaecological cancer, where standard treatments have stopped working, were not tolerated, or no standard treatment currently exists
• People who are able to provide stored tumour tissue samples (10 slides) or fresh tissue taken within the past 3 years
• People who have at least one tumour that can be measured on a scan, as defined by standard research guidelines (RECIST v1.1)
• People whose general physical functioning is rated at 0 or 1 on a standard activity scale (meaning fully active or able to carry out light activities)
• People whose side effects from previous cancer treatments have reduced to a mild level or resolved
• People with no severe heart problems, and whose heart pumping function is at least 50% (as measured by LVEF)
• People whose organ function (such as liver, kidneys, and blood counts) meets the required levels without needing blood transfusions, growth factor drugs, or similar supportive treatments in the 14 days before starting the study drug
• People whose blood clotting results fall within acceptable ranges (INR ≤1.5 and APTT ≤1.5 times the upper limit of normal)
• People whose urine protein levels are within acceptable limits
• People who are not pregnant (confirmed by a negative pregnancy test within 7 days before starting treatment), not breastfeeding, and willing to use reliable contraception during treatment and for 6 months after treatment ends (applies to women who could become pregnant)

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, biological therapy, or other cancer treatments within approximately 4–6 weeks before starting the study (the exact timeframe depends on the treatment type)
• People with a history of serious heart disease
• People with certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or severe irregular heartbeat
• People with active autoimmune or inflammatory conditions
• People who have had another type of cancer that has been progressing or required treatment within the past 5 years
• People with high blood pressure that remains poorly controlled (above 150/100 mmHg) despite taking two blood pressure medications
• People with poorly controlled blood sugar levels
• People with a history of, current, or suspected interstitial lung disease (a condition involving scarring or inflammation of the lungs)
• People with other significant ongoing lung conditions that cause serious breathing difficulties
• People who have had an unstable blood clot event requiring treatment within the 6 months before screening
• People who have cancer that has spread to the brain or the lining around the brain or spinal cord
• People with significant fluid build-up in body cavities (such as around the lungs or abdomen) that is causing symptoms or is poorly controlled
• People with a known allergy or sensitivity to the type of antibody used in the study drug (BL-B01D1) or any of its ingredients
• People whose scans show that the tumour is growing into or wrapping around major blood vessels in the chest, neck, or throat
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who have previously received high cumulative doses of a specific class of chemotherapy drugs called anthracyclines (above 360 mg/m²) (confirm with trial site)
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People who have had a serious infection within 4 weeks before starting the study, or signs of an active lung infection within 2 weeks before starting
• People who have taken part in another clinical trial within 4 weeks before starting this study
• People considered unsuitable for participation for any other reason, as assessed by the trial doctor

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