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:

• People aged 18 or older
• People whose doctors estimate they have a life expectancy of at least 3 months
• People who have been diagnosed with a locally advanced or spreading solid tumour that tests positive for a protein called HER2 (detected by specific lab tests), where surgery or radiation aimed at curing the cancer is not possible, and who have already tried at least 2 standard treatments — or whose cancer has stopped responding to standard treatment, or for whom no standard treatment exists. The cancer types included are: uterine (endometrial) cancer, cervical cancer, ovarian/fallopian tube/peritoneal cancer, bladder (urothelial) cancer, bile duct (biliary tract) cancer, breast cancer, lung cancer, and stomach/oesophageal/gastroesophageal junction cancer
• People who are able to provide existing tumour tissue samples (preserved tissue block or slides) for central laboratory testing to confirm HER2 levels; in some parts of the trial a fresh biopsy may be required (confirm with trial site)
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
• People whose general physical functioning is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity — confirm with trial site)
• People whose side effects from previous cancer treatments have mostly resolved to a mild or negligible level
• People with no serious heart problems, and whose heart pumping function (left ventricular ejection fraction) is at least 50%
• People whose blood clotting, kidney, and other organ function meets specific laboratory thresholds before joining (confirm exact values with trial site)
• People with urine protein levels within acceptable limits (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test taken within 7 days before starting treatment, and must not be breastfeeding
• All participants, regardless of gender, must agree to use adequate contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, targeted therapy, radiation, or other cancer treatments within 4 weeks (or 5 half-lives, whichever is shorter) before the first dose; or who have had major surgery within 4 weeks; or who have received specific older chemotherapy drugs (mitomycin or nitrosoureas) within 6 weeks
• People with a history of serious heart disease
• People with certain heart rhythm abnormalities, including a prolonged QT interval, complete left bundle branch block, or a significant degree of heart block (confirm with trial site)
• People with active autoimmune or inflammatory diseases
• People who have been diagnosed with another cancer within the past 3 years, even if it is currently in remission
• People with high blood pressure that remains poorly controlled despite taking two types of blood pressure medications
• People with significant or poorly controlled lung conditions, such as chronic obstructive pulmonary disease (COPD), asthma, restrictive lung disease, or high blood pressure in the lungs
• People who have had a stroke or a mini-stroke (transient ischaemic attack) within the 6 months before joining
• People who have had a blood clot in a vein (such as deep vein thrombosis or pulmonary embolism) within the 6 months before joining — unless the condition is stable and has been treated with blood-thinning medication for at least 3 weeks
• People with tumours that started in the brain or spinal cord, or with active or untreated cancer spread to the brain; people with previously treated brain metastases may be considered if the condition has been stable for at least 4 weeks, shows no signs of growth, and has not required steroid medication in the 14 days before starting the trial drug (those on very low-dose steroids may still be considered — confirm with trial site)
• People who already have moderate or severe nerve damage (peripheral neuropathy graded 2 or above) before joining
• People who have had an allergic reaction to similar antibody-based treatments, or to any ingredient in the trial drug (BL M07D1)
• People currently taking high-dose steroid medication (more than 10 mg of prednisone or equivalent per day) for reasons other than specific permitted conditions; low-dose steroids and topical or inhaled steroids are generally permitted (confirm with trial site)
• People who have previously received high cumulative doses of a class of chemotherapy drugs called anthracyclines (above 360 mg/m²)
• People with HIV who do not meet specific criteria around viral load, immune cell count, and treatment stability (those who do meet all the specified HIV criteria may still be considered — confirm with trial site)
• People with active Hepatitis C infection (those with a positive antibody test but undetectable virus levels may still be considered — confirm with trial site)
• People with active tuberculosis
• People with serious active infections requiring intravenous antibiotic, antiviral, or antifungal treatment within 1 week before the first dose
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People whom the treating doctor or trial sponsor considers unsuitable for other medical reasons

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