Phase 1 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:

• Adults aged 18 or older who have been diagnosed with an advanced solid tumour (confirmed by laboratory analysis of tumour tissue or cells) that has already been treated with standard treatments, or for which no standard treatment is available.
• People who are willing to provide a stored tumour tissue sample if one exists, or to have a new tissue sample taken before treatment begins if it is safe and medically appropriate to do so.
• People whose cancer can be measured on scans according to standard criteria (known as RECIST v1.1).
• People who are in good enough general health to carry out normal daily activities with little or no limitation (a score of 0 or 1 on a standard health scale used in cancer trials), and who are expected to live at least 12 weeks.
• People whose blood counts, kidney function, liver function, blood clotting, heart function, oxygen levels, and blood protein levels all meet the minimum thresholds required by the trial (confirm specific values with the trial site).
• Women who could become pregnant must agree to use a highly effective form of contraception for the duration of the trial.
• People who are willing and able to follow the trial visit schedule and all other trial requirements, and to sign a consent form.

Who may not be able to join:

• People who have previously been treated with a type of cancer drug called an antibody-drug conjugate (ADC) that contains a topoisomerase I (TOP1) payload.
• People whose cancer has spread to the brain and is currently active or getting worse, or who show signs of cancer spreading along the lining of the brain or spinal cord. (Note: people with brain metastases that have been treated and have been stable for at least 2 months, without needing steroids or anti-seizure medicines, may still be considered.)
• People who still have significant side effects (grade greater than 1) from previous cancer treatments, apart from hair loss or skin colour changes.
• People who have received other cancer treatments or certain other medications within 4 weeks or 5 half-lives of the study drug (whichever is shorter), including other experimental treatments.
• People who have had extensive radiotherapy (covering more than 30% of bone marrow areas) within the past 4 weeks, or targeted palliative radiotherapy outside the measurable tumour area within the past 2 weeks.
• People who have had major surgery within the past 4 weeks, or who have not fully recovered from a recent major surgery.
• People who have had a clinically significant lung condition requiring steroid treatment (such as lung inflammation or scarring) within the past 6 months, or whose screening scans suggest such a condition may be present.
• People with active or chronic inflammation of the pancreas (pancreatitis), or liver cirrhosis — except for people with well-managed cirrhosis classified as Child-Pugh class A (confirm with trial site).
• People who have had signs of serious liver failure — such as yellowing of the skin, confusion related to liver disease, or bleeding from certain blood vessels — within the past 60 days.
• People who have had a liver transplant.
• People who have previously had a bone marrow transplant from a donor.
• People with significant heart conditions, including a heart attack or unstable chest pain within the past 6 months, moderate-to-severe heart failure, uncontrolled high blood pressure, uncontrolled abnormal heart rhythms, or severe narrowing of the aortic heart valve.
• People who have had a blood clot, stroke, or mini-stroke within the past 3 months.
• People with active serious infections, including active hepatitis B, hepatitis C, or HIV. (Note: people with chronic, well-managed hepatitis B, hepatitis C, or HIV infection may be considered eligible if certain conditions are met — confirm with trial site.)
• People with a known or suspected allergy to the study drug or any of its ingredients.
• People who are currently taking part in another clinical trial.
• People who are pregnant or breastfeeding.
• People who have had another cancer diagnosis within the past 3 years, other than the cancer that qualifies them for this trial. (Note: some low-risk or adequately treated cancers may be exceptions — confirm with trial site.)
• People with any other serious medical or psychiatric condition, or abnormal test results, that the treating doctor believes would make participation unsafe or affect how trial results are interpreted.
• People who have had radiation to the chest area within the past year.
• People who have a blockage in the digestive tract, or whose scans show evidence of one, within the past 4 weeks.
• People who have received a live vaccine within the past 30 days.
• People who are currently taking, or cannot stop taking, certain medications that strongly affect how the body processes drugs (strong CYP3A4 or CYP1A2 inducers or inhibitors) within 14 days before starting the study drug, or who cannot stop taking them for the duration of the trial (confirm specific medications with trial site).
• People who have fluid build-up in the abdomen (ascites) that requires frequent drainage procedures to manage symptoms.

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