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:

• You have a confirmed cancer that has spread or cannot be removed by surgery, and standard treatments no longer exist or are no longer working (dose escalation phase), OR you have confirmed high-grade serous ovarian cancer that has stopped responding to platinum-based chemotherapy (meaning the cancer progressed within 6 months of your last platinum treatment) (dose expansion phase)
• Your tumor has tested positive for a protein called HER2, based on specific test results from an approved laboratory (confirm with trial site for exact testing requirements for your situation)
• You are 18 years of age or older
• You have already received at least one prior round of chemotherapy
• You are in reasonably good general health and are able to carry out normal daily activities with little restriction (as measured by a standard medical scoring system)
• Your blood counts and organ function (blood, liver, and kidneys) meet certain minimum levels based on recent lab tests taken within the past 21 days
• Your heart is pumping at least 50% of its normal capacity, confirmed by a heart scan done within 28 days before joining
• You are willing and able to use highly effective contraception during the study and for several months after finishing treatment (requirements differ for women and men — confirm details with trial site)
• If you are HIV-positive, your HIV is well controlled on medication, your viral load is undetectable, and your immune cell count is at an acceptable level
• If you have or have had hepatitis B or C, your virus levels must be undetectable (either through treatment or suppressive therapy)
• If you have cancer that has spread to the brain, it must be stable, you must be off steroid medications, and it must be at least 4 weeks since any radiation treatment to the brain
• You are willing and able to sign a consent form agreeing to participate (or have a legally authorised representative who can do so on your behalf)
• You have stored tissue samples (from a previous biopsy or surgery) available for the study team to test
• For the dose expansion phase only: there must be at least one area of cancer that can safely be biopsied, and your cancer must be measurable on scans

Who may not be able to join:

• You have received chemotherapy or antibody-drug treatment within the past 4 weeks (shorter waiting periods may apply for certain specific treatments — confirm with trial site)
• You have had radiation therapy within the past 4 weeks
• You have had major surgery within the past 4 weeks
• You are currently taking part in another clinical trial involving an experimental treatment
• You have a history of lung inflammation (a condition called interstitial lung disease or pneumonitis) that needed steroid treatment, or you currently have this condition, or it cannot be ruled out based on recent scans
• You have serious breathing problems or a significant lung condition, including conditions such as severe asthma, severe COPD, a recent blood clot in the lungs (within 3 months), or certain autoimmune diseases that can affect the lungs
• You have had a serious allergic reaction to medications similar to the ones used in this trial
• You are currently taking certain medications that strongly affect how the body processes a specific liver enzyme (CYP3A) — confirm with the trial site whether your current medications are affected
• You have had a heart attack within the past 6 months, or you have significant heart failure symptoms, or recent blood tests suggest heart muscle damage
• Your heart's electrical activity shows an abnormal reading (prolonged QT interval) on an ECG
• You have another active cancer diagnosed within the past 3 years (some exceptions may apply, such as certain skin cancers or cancers that have been fully treated — confirm with trial site)
• You have an active infection that requires intravenous (IV) antibiotics, antiviral, or antifungal medication
• You are taking the medications chloroquine or hydroxychloroquine and have not stopped them at least 14 days before starting the trial
• You have ongoing side effects from previous cancer treatments that have not yet resolved to a mild or baseline level (hair loss is an exception)
• You have a mental health condition or personal circumstances that would make it difficult to follow the study requirements
• You are pregnant or breastfeeding
• You have received a live vaccine (such as certain flu or travel vaccines) within the past 30 days

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