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:

• People who are able to give signed consent and agree to follow the study's requirements.
• People who are willing to provide an optional genetic research consent form before any genetic samples are collected (declining this does not prevent someone from joining the study).
• People who are 18 years of age or older at the time of signing the consent form.
• People who are willing to provide tumour tissue samples (either stored or newly collected) as required by the specific study module they are enrolled in.
• People who have previously received certain targeted cancer therapies (such as antibody-drug conjugates) and, where applicable, are willing to have a fresh tumour biopsy taken, unless a stored sample was collected after that previous treatment.
• People whose general physical functioning is rated at a level where they are fully active or have only minor restrictions on physically demanding activity (confirm with trial site).
• People with advanced solid tumours who have already received appropriate prior treatment for their cancer type and stage, or where a clinical trial is considered the best next option by their doctor — including those who could not tolerate or were unable to have standard treatments.
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1), including in some cases a previously treated area if the cancer is growing there again.
• People with a life expectancy of at least 12 weeks.
• People whose organ function (such as kidneys, liver, and bone marrow) meets the study's required levels.
• People who are able and willing to use the required contraception methods for the duration of the study and for 8 months after their last dose of the study treatment, in line with the detailed requirements below:
  • Male participants who are sexually active with a female partner who could become pregnant must use a condom plus an additional contraceptive method, and must not donate or freeze sperm during the study and for 8 months after the last dose.
  • Female participants who could become pregnant must have a negative pregnancy test within 72 hours before their first dose and before each new treatment cycle, and must use a highly effective form of birth control (such as an implant, intrauterine device, hormonal injection, or the contraceptive pill) throughout the study and for 8 months after the last dose. Their male partner must also use a condom during this time. Female participants must not donate or retrieve eggs for their own use during the study and for 8 months after the last dose.

Who may not be able to join:

• People who have cancer pressing on the spinal cord, or who have a history of cancer spreading to the membranes surrounding the brain and spinal cord.
• People with cancer that has spread to the brain, unless it is stable, not causing symptoms, and has not required ongoing steroid treatment above a certain dose for at least 4 weeks before starting the study.
• People who have recently taken certain medications specified in the study protocol without a sufficient break before the study starts.
• People who still have significant side effects (rated Grade 2 or higher) from previous cancer treatments, with some exceptions such as skin colour changes, hair loss, hormone-related conditions managed with replacement therapy, or stable mild nerve-related symptoms.
• People with an active infection, including tuberculosis, active hepatitis B, active hepatitis C, or HIV that is not well controlled. People with a past or resolved hepatitis B or C infection may still be considered depending on specific test results and conditions (confirm with trial site).
• People who have active lung inflammation (a condition called ILD or pneumonitis), or who have a history of non-infectious lung inflammation that needed steroid or oxygen treatment, or where this condition cannot be ruled out on scans at the start of the study. People with a history of radiation-related lung inflammation that has fully resolved and needed no ongoing steroid treatment may still be considered.
• People with a history of another cancer, except those whose previous cancer was treated with the intent to cure with no signs of return for at least 2 years, or who had certain low-risk skin cancers, pre-cancerous conditions, or localised non-invasive disease that is being monitored.
• People with certain heart conditions, including:
  • A history of certain serious heart rhythm problems that cause symptoms or require treatment
  • Uncontrolled high blood pressure
  • A heart attack, unstable chest pain, or heart surgery within the past 6 months
  • A stroke, mini-stroke, or blood flow problem to the brain within the past 6 months
  • Symptomatic heart failure
  • A diagnosis of heart muscle disease considered clinically significant by the doctor
  • Severe heart valve disease that has not been corrected
  • An abnormal heart electrical reading (QTcF above 470 milliseconds on average across three tests)
  • Any factor that increases the risk of abnormal heart rhythms, such as a genetic condition affecting heart rhythm or a family history of this
• People with serious ongoing or unresolved illnesses within the past 12 months, including severe ongoing digestive conditions causing diarrhoea, or mental health or personal circumstances that, in the doctor's view, would make it difficult to follow the study requirements safely.
• People with substance use issues or other medical conditions that, in the doctor's view, would make participation unsafe or affect the study results.
• People who have received a live vaccine within 30 days before their first dose of the study treatment. (Participants already in the study should not receive live vaccines during treatment or for 3 months after the last dose. COVID-19 vaccines may be permitted at the doctor's discretion, following a benefit-risk assessment and local guidelines.)
• Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study period.
• People currently taking part in another interventional clinical trial (observational studies or follow-up phases of other studies may be acceptable; confirm with trial site).
• People with a known allergy or sensitivity to the study treatment or any of its ingredients.
• People who are involved in planning or running this study (including staff at the trial site or at the study sponsor).
• People who, in the doctor's judgement, are unlikely to follow the study procedures and requirements.
• People who have previously been enrolled in this same study.

Note: Additional eligibility requirements may apply depending on the specific study module a person is being considered for.

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