Phase 1 Oesophageal 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 who have voluntarily agreed to take part and follow the study requirements
• People with a life expectancy of at least 3 months
• People with a locally advanced or metastatic solid tumour that has come back or kept growing after at least one round of prior treatment, with no remaining standard treatment or curative options available — specific tumour types include stomach or gastroesophageal junction cancer, pancreatic cancer, oesophageal cancer, bile duct cancers, or other solid tumours shown to carry a protein called CLDN18.2; depending on the tumour type and its specific molecular features, certain targeted treatments must have already been tried before joining
• People who can provide an existing tumour tissue sample (a preserved tissue block or slides); if no existing sample is available, a fresh biopsy will be required
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People who are generally well enough to carry out light activity and care for themselves (ECOG performance status of 0 or 1)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level (Grade 1 or below), with exceptions allowed for hair loss and certain hormone-related conditions that are being managed
• People whose heart is functioning well, with the heart's pumping strength (left ventricular ejection fraction) at 50% or above
• People whose blood counts, liver function, kidney function, and blood clotting levels all meet the specific thresholds required by the trial (confirm with trial site for exact values)
• People with a urine protein level within acceptable limits
• People who are sexually active and able to become pregnant or father a child, and who agree to use highly effective contraception during the study and for a set period after the last dose (7 months for women, 4 months for men), along with an additional barrier method
• Women who could potentially become pregnant must have a negative pregnancy blood test at the start of the trial and must not be breastfeeding

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, radiation, targeted therapy, or other cancer treatments within roughly the past 4 weeks (or within 5 half-lives of the drug, whichever is shorter); or major surgery within the past 4 weeks; or certain specific chemotherapy drugs (mitomycin or nitrosoureas) within the past 6 weeks
• People with a history of serious heart disease, such as significant heart failure, a heart attack, or unstable chest pain within the past 6 months
• People with certain abnormal heart rhythm findings, including a prolonged QT interval, complete left bundle branch block, or a significant degree of heart conduction block
• People with active autoimmune or inflammatory diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring systemic treatment; some well-controlled conditions such as type 1 diabetes or hypothyroidism may still be eligible (confirm with trial site)
• People with a history of another cancer, unless it was a skin cancer or early-stage cancer treated with curative intent and there has been no sign of disease for at least 3 years before joining
• People whose high blood pressure is not well controlled even with two types of blood pressure medication
• People with serious or poorly controlled lung conditions such as severe COPD, asthma, restrictive lung disease, or pulmonary hypertension
• People who have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, or who currently have this condition, or where it cannot be ruled out on imaging
• People who have had a stroke or mini-stroke (TIA) within the past 6 months
• People who have had a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past 6 months, unless clinically stable and on appropriate blood-thinning treatment for at least 3 weeks
• People with tumours originating in the brain, or with active or untreated cancer that has spread to the brain or its surrounding membranes; people with previously treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site)
• People who already have moderate or severe nerve damage in their hands or feet (Grade 2 or higher peripheral neuropathy)
• People who have had a severe allergic reaction to similar types of antibody-based treatments or to any component of the study drug (BL-M05D1)
• People taking systemic steroid medications at a dose above the equivalent of 10 mg of prednisone per day (some exceptions apply — 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 infection, unless the virus is undetectable, immune cell counts are adequate, and stable antiviral treatment has been in place for at least 4 weeks (confirm with trial site for full criteria)
• People with active hepatitis B infection; those with an inactive chronic hepatitis B infection may be considered if specific viral load, liver function, and treatment criteria are met (confirm with trial site)
• People with active hepatitis C infection; those with a positive hepatitis C antibody test may still be considered if a specific RNA test comes back negative (confirm with trial site)
• People with active tuberculosis
• People with a serious active infection requiring intravenous antibiotics, antivirals, or antifungals within the week before starting treatment
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with any other condition that the trial doctors consider makes participation unsuitable

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