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 willing to sign a consent form and follow the study requirements
• People aged 18 or older
• People whose doctors expect them to live for at least 3 months
• People who have been confirmed through a tissue or cell sample to have epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
• People who have previously been treated with a platinum-based chemotherapy and whose cancer has been confirmed to have come back in a way that no longer responds to platinum treatment
• People who have received between 1 and 3 prior rounds of cancer treatment, and whose cancer has shown signs of growing during or after the most recent treatment, or who could not tolerate that treatment
• People whose cancer has a protein called folate receptor-alpha (FRα) must have already received a specific treatment called mirvetuximab soravtansine before the cancer got worse (confirm with trial site)
• People who are able to provide a stored or fresh tumour tissue sample taken within the past 3 years
• People who have at least one tumour that can be measured on a scan, according to standard measurement rules
• People who are well enough to carry out basic daily activities, rated at level 0 or 1 on a standard health performance scale
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
• People with no serious heart problems and whose heart pumping function is at least 50%
• People whose organ function (such as liver, kidneys, and blood counts) meets the levels required by the trial (confirm exact levels with trial site)
• People whose blood clotting test results fall within the required ranges
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and all participants must use effective barrier contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have received chemotherapy, targeted therapy, or biological therapy within the 4 weeks before joining, or palliative radiation therapy within the past 2 weeks
• People whose cancer could potentially be treated with a focused local or surgical approach to the affected area
• People who have previously received certain types of antibody-drug treatments (called ADCs) targeting specific proteins called topoisomerase I, EGFR, or HER3 as part of their first round of treatment
• People with a history of serious heart or stroke-related disease
• People who have had blood clot-related events requiring treatment within the 6 months before screening
• People with certain heart rhythm or electrical conduction problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• People diagnosed with another active cancer within the 3 years before joining the trial
• People with high blood pressure that remains poorly controlled even when taking two blood pressure medications
• People with poorly controlled blood sugar levels
• People who have had radiation-related lung inflammation, or who have a history of a lung condition called interstitial lung disease (ILD)
• People with serious lung disease that significantly affects their ability to breathe
• People with active cancer spread to the brain or central nervous system
• People who have had a serious infection within 4 weeks before joining, or signs of a lung infection or active lung inflammation within 2 weeks before joining
• People with large or symptomatic fluid build-up in the body that is not well controlled
• People whose scans show the tumour has grown into or around major blood vessels in the abdomen, chest, neck, or throat
• People with serious wounds, ulcers, or broken bones that have not healed within 4 weeks before signing the consent form
• People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form
• People with inflammatory bowel disease, large amounts of bowel removed, immune-related bowel conditions, bowel obstruction, or ongoing diarrhoea
• People who have had an allergic reaction to similar types of antibody-based medicines or to any ingredient in the study drug BL-B01D1
• People who have previously had a stem cell transplant (either their own or from a donor)
• People who test positive for HIV, or who have an active hepatitis B or hepatitis C infection
• People with a history of serious neurological or psychiatric illness
• People who have taken part in another trial using an unapproved drug or treatment within 4 weeks before joining
• People who have received a live vaccine or are scheduled to receive one within 28 days before joining the trial
• People who the trial doctor considers unsuitable for any other medical or personal reason

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