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 have read, understood, and signed the informed consent form before any trial procedures begin
• People who are able to follow the trial's requirements and attend all necessary visits
• People aged 18 years or older
• People who have a confirmed diagnosis of a solid tumour cancer that has spread or come back, and is getting worse, with the diagnosis confirmed in a pathology report
• People whose cancer has been shown to be progressing before joining the trial
• People who have already tried all standard treatments that are expected to work better than the trial drug for their specific cancer
• People who have a stored tissue sample with enough tumour material for testing (20 slides), or who are able to have a new biopsy taken if needed
• People whose tumour has a confirmed genetic change (a complete deletion) in one of these genes — SMARCB1, SMARCA4/2, ARID1A/B, PBRM1, BAP1, SMARCC1/2, or another related gene — detected by an approved genetic test, and confirmed by a centralised tissue stain test; the tissue used for this testing must be less than 3 years old, or a new biopsy will need to be done; each group (cohort) also has a limit on how many prior treatments a person may have had (confirm with trial site for details of your specific cohort)
• People who have at least one measurable area of cancer that has not been previously treated with radiation, visible on a CT or MRI scan, and able to be monitored over time
• People with a good general physical condition, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities), with no recent decline
• People with an estimated life expectancy of more than 12 weeks
• People whose blood counts and organ function meet specific thresholds, confirmed by blood tests taken within 3 days before starting treatment (confirm with trial site for detailed values)
• Women who could potentially become pregnant must have a negative pregnancy blood test during screening, and another negative test within 72 hours before starting treatment (or a negative urine test within 24 hours), and must agree to use highly effective contraception plus a barrier method, or abstain from sex, during the trial and for 3 months after the last dose
• Women who are breastfeeding must agree to stop breastfeeding during the trial and for 3 months after the last dose
• Sexually active men whose partner could become pregnant must agree to use highly effective contraception during the trial and for 3 months after the last dose, or be surgically sterile
• All participants must agree not to donate blood during the trial or for 3 months after the last dose
• Male participants must agree not to donate or freeze sperm from screening onwards, throughout the trial, and for at least 3 months after the last dose
• Female participants must agree not to donate eggs or retrieve eggs for their own use from screening onwards, throughout the trial, and for at least 3 months after the last dose
• People who are willing and able to follow all study visits and procedures as required by the trial
• People who are covered by a social security system or equivalent (this appears to be a French regulatory requirement — confirm with trial site)

Who may not be able to join:

• People who have taken part in another clinical trial involving an investigational treatment in the last 4 weeks (observational studies without treatment may be acceptable — confirm with trial site)
• People who received their last cancer treatment less than 21 days before starting the trial drug, or less than five half-lives of that previous treatment, whichever is the longer period
• People who have had radiation therapy covering more than 20% of their bone marrow within the past 2 weeks, curative radiation or major surgery within the past 4 weeks, or palliative radiation within the past 2 weeks
• People who have had another separate cancer within the past 5 years, with some exceptions for certain fully treated and low-risk cancers such as some skin cancers or carcinoma in situ (confirm with trial site)
• People who have been taking high-dose steroid or immunosuppressive medications in the 2 weeks before starting the trial, or who are expected to need them during the trial (some low-dose or inhaled steroid uses may be permitted — confirm with trial site)
• People who still have significant side effects from previous cancer treatments that have not improved to a mild level (except hair loss)
• People with a known history of severe allergic reactions to certain types of antibody-based medicines, or a known allergy to the trial drug or its ingredients
• People with serious or uncontrolled heart conditions, including abnormal heart rhythm, heart attack within the past 6 months, uncontrolled chest pain, severe heart failure, uncontrolled high blood pressure, or poor heart pumping function below certain thresholds (confirm with trial site for specific values)
• People who have tested positive for HIV or have AIDS
• People with an active hepatitis B or hepatitis C infection confirmed by a positive test within the past 28 days
• People with active tuberculosis
• People with an ongoing, uncontrolled serious infection (bacterial, fungal, or viral) requiring intravenous treatment (localised skin or nail fungal infections may be acceptable — confirm with trial site)
• People with any other serious uncontrolled medical condition that the trial doctor considers poorly managed, including certain bleeding disorders
• People currently taking moderate or strong medications that strongly affect how the body processes the trial drug (a specific class of drugs known as CYP3A inducers — confirm with trial site for a list)
• People who have received a live or weakened live vaccine within 4 weeks before starting the trial, or who may need one during the trial (COVID-19 vaccines are an exception)
• People who have had major surgery within 20 days before starting the trial, or who are expected to need major surgery during the trial
• People with pain caused by their cancer that is not being adequately managed; pain medication must be at a stable dose before joining
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month (people with a permanent drainage catheter in place may be eligible — confirm with trial site)
• People with uncontrolled high calcium levels in the blood that require ongoing medication to manage
• People with a history of cancer spreading to the lining of the brain or spinal cord
• People with brain metastases that are causing symptoms or are not controlled, or that require increasing steroid doses or stable steroid doses above a certain level (confirm with trial site)
• People with spinal cord compression unless their condition has been clinically stable for at least 2 weeks before starting the trial
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not using effective contraception
• People who have previously been treated with EZH2 or EZH1/2 inhibitor drugs, except in one specific cohort (Cohort 1A) where these drugs have been approved
• People with any other condition that, in the trial doctor's judgement, would affect the safety or accuracy of the trial results
• People under legal guardianship, detained by a court or administrative order, or unable to give their own consent

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