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 willing to take part in clinical research, have been fully informed about the study, and are willing to follow all study procedures
• People aged 18 to 75 years old at the time of signing the consent form
• People in Cohort 1 with metastatic or returning cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) confirmed by tissue or cell testing; or people in Cohort 2 with a confirmed diagnosis of high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
• People in Cohort 1 whose cervical cancer has stopped responding to, or who could not tolerate, standard treatments (which may include platinum-based chemotherapy with or without an immune checkpoint inhibitor, depending on a specific protein marker result); or people in Cohort 2 whose ovarian cancer has stopped responding to platinum-based chemotherapy under specific timing conditions (confirm with trial site)
• People who have at least one measurable area of cancer that can be assessed by standard imaging criteria within 4 weeks before starting the study drug
• People who are able to provide a tumour tissue sample for testing of a specific protein marker (PD-L1) during the screening period, where possible
• People who have waited a sufficient period of time since their last cancer treatment before starting the study drug, and whose side effects from previous treatments have mostly resolved (confirm with trial site for specific waiting times)
• People with a good general physical performance level, rated 0 or 1 on a standard scale, in the week before joining the study
• People with an expected survival of at least 3 months
• People whose organ function blood test results, taken within the 14 days before starting the study drug, meet the required levels without recent blood transfusions or certain injections
• Women who could become pregnant must agree to use at least one highly effective form of contraception during the trial and for at least 6 months after the last dose, and must have a negative pregnancy test within 7 days before enrolling

Who may not be able to join:

• People who have had a second type of cancer diagnosed within the 2 years before joining the trial
• People who are planning to have, or have previously had, an organ or bone marrow transplant
• People who have cancer that has spread to the brain or the lining around the brain, where this is causing symptoms, has not been treated, or is getting worse
• People who still need frequent fluid drainage from around the lungs, heart, or abdomen despite appropriate treatment
• People who have radiation-related lung inflammation of any grade, a history of a scarring lung condition, or a serious lung disease causing significant breathing problems
• People with poorly controlled heart or blood vessel conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack or stroke in the past 6 months, uncontrolled irregular heartbeat, or high blood pressure that remains above a certain level despite treatment (confirm with trial site for specific measurements)
• People who previously had to permanently stop immunotherapy due to side effects, or who have had a grade 2 or higher immune-related lung or heart muscle inflammation
• People with an active or suspected condition where the immune system attacks the body's own tissues (certain exceptions apply, such as controlled thyroid or Type 1 diabetes conditions managed with medication)
• People who have taken high-dose steroid tablets or other immune-suppressing medicines within 14 days before starting the study drug (certain limited exceptions apply)
• People who have an active serious infection requiring intravenous antibiotics within 2 weeks before joining the trial
• People who have received a live or weakened live vaccine within 4 weeks before starting the study drug (standard inactivated flu vaccines are permitted)
• People who have taken certain strong medications known to affect how specific liver enzymes process drugs, within 2 weeks before joining the trial (confirm with trial site)
• People with a known history of severe allergic reactions to monoclonal antibody medicines or to any ingredient in the study drug, or who have previously received a specific type of cancer drug known as an ADC containing a topoisomerase I inhibitor
• People with active tuberculosis
• People with HIV infection
• People with active Hepatitis B or Hepatitis C infection, or both at the same time
• Women who are pregnant or breastfeeding
• People who the trial doctor considers unsuitable for any other reason

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