Phase 2 Stomach 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:

• People who are willing and able to give written consent to participate (or whose legal representative can do so on their behalf).
• People aged 18 or older at the time of signing the consent form.
• People with a solid tumour that has been confirmed by laboratory testing of tissue or cells, which has spread locally or to other parts of the body, and where standard treatments have stopped working, are not tolerable, or no standard treatment exists — including but not limited to cancers of the stomach, the junction of the stomach and oesophagus, the pancreas, the oesophagus, the ovaries, the lungs, the bowel, or the bile ducts.
• In the first phase of the trial (dose finding), people do not need to have a tumour that produces a specific protein called CLDN18.2, but a tumour tissue sample must be provided so testing for this protein can be done.
• In the second phase of the trial (dose expansion), only people whose tumour has been confirmed to produce the CLDN18.2 protein — tested in a central laboratory using the most recently available tumour sample, or a new biopsy if no suitable archived sample exists — are eligible.
• People whose general health and ability to carry out daily activities meets the trial's fitness level requirement (scored 0, 1, or 2 on a standard medical scale called the ECOG scale).
• People whose life expectancy is estimated to be more than 12 weeks.
• People who have at least one area of cancer that can be measured using standard imaging criteria (RECIST version 1.1).
• People whose blood counts, liver function, kidney function, and heart function meet specific laboratory thresholds set by the trial, including: sufficient levels of white blood cells, platelets, and haemoglobin; liver enzyme and bilirubin levels within the required range; adequate kidney function based on a calculated measure called creatinine clearance; a heart electrical reading (QTc interval) within an acceptable range; and a heart pumping function (LVEF) of 50% or above.
• Women who could become pregnant and who agree to use a highly effective form of contraception (such as implants, injections, the pill, an intrauterine device, complete abstinence, or a partner who has had a vasectomy) throughout the study and for at least 180 days after the last dose.
• Men who have female partners who could become pregnant and who agree to use an accepted form of contraception (such as abstinence, vasectomy, or a condom with spermicide) throughout the study and for 180 days after the last dose, and who also agree not to donate sperm during that same 180-day period.

Who may not be able to join:

• People who have previously had a severe allergic reaction or intolerance to a monoclonal antibody (a type of laboratory-made protein used as a medicine), including humanised or chimeric types.
• People who have previously had a severe allergic reaction or intolerance to a class of drugs called Topoisomerase I Inhibitors or related treatments (such as irinotecan, topotecan, or certain antibody-drug combinations), or to any ingredient in the trial drug XNW27011.
• People with a history of or currently living with: an immune deficiency condition or who have had an organ transplant; a heart attack in the past 6 months; hospitalisation for heart failure in the past 12 months; severe or unstable chest pain; certain heart surgeries; a serious heart failure classification (NYHA grade III or IV); or blood pressure that cannot be controlled and remains very high at rest.
• People with certain other serious ongoing health conditions that could affect safety or the ability to complete the study, such as active bleeding in the digestive system, active stomach ulcers, bowel blockage, serious lung conditions, kidney failure, or poorly controlled diabetes (confirm with trial site for specific thresholds).
• People with brain tumours (either originating in the brain or that have spread there) that are currently uncontrolled — though people whose brain tumours have been stabilised or whose local treatment has ended may be considered (confirm with trial site).
• People who have had a significant stroke or bleeding in the brain within the 6 months before the first dose.
• People with a past or current mental health condition that is difficult to control.
• People with HIV infection, active or treatable syphilis infection, or active hepatitis B or C infection.
• People who have had an active infection requiring treatment taken throughout the body within the 2 weeks before the first dose.
• People who have an uncontrolled build-up of fluid in the chest or abdomen that cannot be managed by drainage or other methods.
• People who still have side effects from previous cancer treatments that have not reduced to a mild or resolved level (with the exception of hair loss).
• People who have taken part in another clinical drug trial within 4 weeks before the first dose.
• People who have received cancer treatments such as chemotherapy, radiation therapy, immunotherapy, or biological therapy within 3 weeks before the first dose; or targeted therapy, certain herbal or traditional medicines within 2 weeks; or radiation to bone metastases within 2 weeks; or certain specific chemotherapy drugs (nitrosoureas or mitomycin C) within 6 weeks.
• People who have had major surgery or an interventional procedure within 4 weeks before the first dose (routine tumour biopsies are generally excepted — confirm with trial site).
• People who have been on long-term high-dose steroid therapy (confirm with trial site for specific thresholds and exceptions for short-term or recently stopped use).
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the study.
• People who have recently taken certain medications that strongly affect how the liver processes drugs (specific drug classes called strong CYP3A4 inhibitors or inducers, or strong CYP2D6 inhibitors) within 2 weeks or five half-lives of that medication, whichever is shorter.
• Women who are pregnant, breastfeeding, or who return a positive pregnancy test during the screening period.
• In the second phase only, people who have previously been treated with certain targeted therapies directed at the CLDN18.2 protein (such as CLDN18.2-targeting antibody-drug conjugates or CAR-T cell therapies).
• In the second phase only, people who have had more than one type of primary cancer in the past 5 years, with certain exceptions for adequately treated skin cancers or cancers confirmed as fully cured (confirm with trial site).
• People who, in the investigator's judgement, are unlikely to be able to follow the study requirements or who are otherwise considered unsuitable for participation.

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