Phase 1 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 (for the first part of the study), or 18 or older (for the second part)
• You have been diagnosed with a locally advanced or spreading solid tumour (such as a digestive tract tumour) that tests positive for or shows low levels of a protein called HER2, confirmed by tissue or cell testing
• Doctors expect you to live for at least 3 more months
• You are able to provide a stored or fresh tumour tissue sample from within the last 2 years
• You have at least one tumour that can be measured on a scan, as defined by standard research guidelines
• You are reasonably active and able to care for yourself (rated 0 or 1 on a standard activity scale)
• Any side effects from previous cancer treatments have mostly cleared up (to a mild level or better)
• Your heart is functioning well, with a pumping strength of 50% or higher
• Your blood, kidney, and liver function meet the required levels (confirm with trial site)
• Your blood clotting results are within an acceptable range
• The level of protein in your urine is within an acceptable limit
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment, and you must not be breastfeeding; all participants (male or female) must use reliable contraception during treatment and for 6 months after it ends

Who may not be able to join:

• You have received certain cancer treatments (such as chemotherapy or biological therapy) within the last 4 weeks, or some specific drugs (like mitomycin) within the last 6 weeks
• You have a history of serious heart disease
• You have certain heart rhythm problems, such as a prolonged QT interval, a specific type of heart block, or frequent uncontrolled irregular heartbeat
• You have an active autoimmune or inflammatory condition
• You have been diagnosed with another cancer within the last 5 years
• You have high blood pressure that is not well controlled even with two blood pressure medications
• Your blood sugar levels are poorly controlled before starting the trial
• You have, or are suspected of having, a lung condition called interstitial lung disease (ILD), or have needed steroid treatment for it
• You have a serious lung condition that significantly affects your breathing
• You have large or symptomatic fluid build-up in the body that is not well controlled
• Scans show the tumour has grown into or is wrapped around major blood vessels in the chest, neck, or throat
• You have had an unstable blood clot requiring treatment within the last 6 months
• Your cancer has spread to the brain and is currently active
• You have a known allergy to the study drug (BL-M17D1) or similar antibody-based medicines
• You have had an organ transplant or a stem cell transplant from a donor
• You have HIV, active tuberculosis, active hepatitis B, or active hepatitis C
• You have had a serious infection requiring treatment within the last 4 weeks, or signs of a lung infection within the last 2 weeks
• You have taken part in another clinical trial within the last 4 weeks
• You are pregnant or breastfeeding
• You have a condition called superior vena cava syndrome that limits fluid intake (confirm with trial site)
• You have a history of serious neurological or mental health illness
• You have a serious wound, ulcer, or broken bone that has not healed within the last 4 weeks
• You have had significant bleeding or a strong tendency to bleed within the last 4 weeks
• You have a history of bowel obstruction, inflammatory bowel disease, large bowel surgery, Crohn's disease, ulcerative colitis, or long-term diarrhoea
• You have received or are due to receive a live vaccine within 28 days before starting the trial
• The trial doctor does not consider you suitable for any other reason

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