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 female and aged 18 or older at the time of signing the consent form
• People who are willing and able to sign the consent form and follow the study requirements
• People who have been diagnosed (confirmed by lab testing of tissue) with advanced (cannot be removed by surgery) or metastatic high-grade serous ovarian cancer, primary peritoneal cancer, fallopian tube cancer, or high-grade endometrioid ovarian cancer
• People whose tumor tests positive for a protein called CLDN6 (tumor tissue must be submitted for testing before the study begins)
• People whose cancer has become resistant to platinum-based chemotherapy, meaning the cancer came back or got worse within a specific time window after platinum treatment (confirm exact details with trial site)
• People who have received at least 1 but no more than 3 prior cancer treatment regimens, and for whom a single treatment drug is appropriate as the next step (confirm how prior lines are counted with trial site)
• People who have measurable disease visible on imaging scans
• People who are generally well enough to carry out daily activities with no or minimal limitations (confirm with trial site)
• People whose blood, kidney, liver, and heart function meet the required laboratory levels (confirm specific values with trial site)
• People who test negative on a blood pregnancy test within 72 hours before starting the study drug
• People who agree to use a highly effective form of contraception from the first dose of study treatment through 7 months after the last dose, or who are not able to become pregnant
• People who agree not to donate eggs from the first dose of study treatment through 7 months after the last dose
• People who agree not to breastfeed from the first dose of study treatment through 90 days after the last dose

Who may not be able to join:

• People who have not yet recovered from serious side effects of previous cancer treatment (minor hair loss or lab abnormalities that still meet eligibility requirements are generally acceptable)
• People with certain other types of ovarian tumours, including clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed, low-grade, borderline, or non-epithelial ovarian cancers
• People whose cancer did not respond to, or got worse within 3 months of, their first platinum-based chemotherapy (known as platinum-refractory disease)
• People who received certain other cancer treatments within the 14 to 28 days before the first study dose (the waiting period depends on the type of treatment; confirm with trial site)
• People who have previously been treated with a CLDN6-targeting therapy or a specific type of drug called an MMAE-containing antibody-drug conjugate
• People with brain metastases that are growing or causing symptoms (stable, previously treated, and symptom-free brain metastases may be permitted; leptomeningeal disease is not permitted)
• People with moderate or severe nerve damage in the hands or feet (Grade 2 or higher peripheral neuropathy)
• People who have had non-infectious lung inflammation (pneumonitis or interstitial lung disease) within the past 6 months
• People with serious uncontrolled medical conditions, active uncontrolled infections, or psychiatric conditions that would prevent them from safely participating or giving informed consent
• People with significant heart problems, including severe heart failure, unstable chest pain, a heart attack within the past 6 months, certain irregular heart rhythms, or other unstable heart conditions (some heart medications may also be a factor; confirm with trial site)
• People with a known history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People who have had another cancer within the past 3 years, with some exceptions such as certain treated skin cancers or low-risk conditions (confirm with trial site)
• People with active serious infections
• People with a seizure disorder that requires medication
• People with a known allergy or intolerance to any component of the study drug
• People who have previously had a bone marrow or organ transplant from another person
• People with any other condition that the study doctor believes would make participation unsafe or affect the reliability of safety results
• People currently taking certain medications that strongly affect a liver enzyme called CYP3A4 (confirm specific medications with trial site)
• People currently taking certain medications that block a protein called P-glycoprotein (confirm specific medications with trial site)

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