Phase 3 Stomach 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:

• You are willing to sign a consent form and agree to follow the study rules
• You are between 18 and 75 years old
• Your doctors expect you to live for at least 3 months
• You have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe that cannot be removed by surgery or has spread to other parts of the body, confirmed by a tissue test
• Your cancer got worse after receiving the standard first-line treatment, and this is visible on scans
• You are able to provide a stored or new tissue sample from your tumour
• There is at least one tumour that can be measured on a scan
• You are generally able to carry out daily activities with little or no limitation (as assessed by a standard medical scale)
• Any side effects from previous cancer treatments have mostly resolved
• Your heart is functioning well enough, with a specific heart pumping measurement of at least 50%
• Your blood, kidney, and liver function meet the required levels (confirm with trial site)
• Your blood clotting levels are within an acceptable range
• Your urine protein levels are within acceptable limits
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants must use reliable contraception during treatment and for 6 months after finishing
• There are no gender restrictions for joining

Who may not be able to join:

• You have received certain prior anti-tumour treatments (confirm with trial site for specifics)
• Your tumour tests positive for a protein called HER2
• You have a history of serious heart or stroke-related conditions
• You have certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, or third-degree heart block (confirm with trial site)
• You had a serious blood clot event requiring treatment within the past 6 months
• You have an active autoimmune disease or ongoing inflammatory condition
• You have been diagnosed with another cancer within the past 3 years
• Your high blood pressure is not well controlled even with two blood pressure medications
• You have a history of a lung condition called interstitial lung disease that required steroid treatment
• You have another lung condition that causes significant breathing problems
• You had an infection that needed medical treatment within 2 weeks before joining the study
• Your blood sugar levels are poorly controlled
• Your cancer has spread to your brain or spinal cord and is currently active
• You have a significant build-up of fluid in body cavities (such as the abdomen or chest) that is causing symptoms or is hard to control
• Scans show that the tumour is growing into or wrapping around major blood vessels in the chest, neck, or throat
• You have had an allergic reaction to certain types of antibody-based medicines, or are allergic to any ingredient in the study drug (BL-M05D1)
• You have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• You are HIV positive, or have active tuberculosis, active hepatitis B, or active hepatitis C
• You have an active infection that requires treatment throughout your whole body
• You are pregnant or breastfeeding
• You have had bleeding from veins in your stomach or food pipe requiring treatment in the past 3 months
• You have a history of bowel blockage, inflammatory bowel disease, or major bowel surgery
• You have other serious health or test result abnormalities, or are unlikely to be able to follow the study requirements, as judged by the doctor running the trial

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