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:

• Adults aged 18 or older, of any gender, who give their informed consent to participate.
• People with a confirmed diagnosis (through tissue testing) of a locally advanced, returning, or spread solid tumour — such as colorectal, stomach, liver, head and neck, breast, lung, oesophageal cancer, or similar — whose cancer has worsened or who could not tolerate at least one previous treatment, and for whom no suitable standard treatment is available or appropriate.
• People who have at least one tumour that can be measured using standard imaging guidelines (known as RECIST 1.1); a previously treated area may count only if there is documented evidence the cancer has grown there after radiation.
• People who have stored tumour tissue samples available, or who agree to have a tumour biopsy taken so that certain protein levels and other markers can be tested.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to partially restricted but able to care for themselves (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People whose bone marrow is producing enough blood cells to meet specific minimum levels for white blood cells, platelets, and haemoglobin (slightly different thresholds apply for people with liver cancer — confirm with trial site).
• People whose liver function blood test results fall within acceptable ranges, with slightly higher allowances for those with liver cancer, liver spread, or a condition called Gilbert's syndrome (confirm with trial site).
• People whose kidney function meets a minimum level based on a standard calculation, and whose urine protein levels are within acceptable limits (confirm with trial site).
• People whose blood clotting test results fall within acceptable ranges (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must use effective contraception during the trial and for 6 months after the last dose; this does not apply to those who have had surgical sterilisation or who are postmenopausal.
• Men must agree to use effective contraception during the trial and for 6 months after the last dose.

Who may not be able to join:

• People who have previously been treated with any CD47 antibody, SIRPα antibody, or related CD47/SIRPα protein therapy (confirm with trial site if unsure).
• People who have previously received certain specialised cell-based cancer therapies (such as CAR-T, TCR-T, or TIL), received an anti-cancer vaccine, or received a live vaccine within 4 weeks before the first dose.
• People who have received certain anti-cancer treatments too recently before the first dose — specific waiting periods apply depending on the type of treatment (for example, 3 weeks for chemotherapy or immunotherapy, 6 weeks for certain chemotherapy agents, and 2 weeks or longer for some oral or targeted therapies); some anti-cancer herbal or traditional medicines must also be stopped before joining; recent radical radiotherapy within 3 months is excluded, though recent palliative radiotherapy may be allowed under specific conditions (confirm with trial site).
• People who have taken an experimental drug within 28 days before the first dose, or who are currently enrolled in another clinical treatment trial (participation in a non-treatment observational study, or being in a follow-up period after finishing another trial, may be acceptable — confirm with trial site).
• People who had major surgery (not including needle biopsies) or a significant injury within 4 weeks before the first dose, or who would need planned surgery during the trial.
• People who have taken high-dose steroid medications or other immune-suppressing drugs within 14 days before the first dose; some exceptions apply for inhaled, topical, or short-term preventive steroid use (confirm with trial site).
• People with active, symptomatic cancer spread to the brain or the lining of the brain that the trial doctors consider unsuitable for enrolment.
• People who have previously had a severe immune-related side effect (grade 3 or higher) from immunotherapy, or a grade 2 or higher immune-related heart inflammation from prior immunotherapy.
• People with serious or uncontrolled medical conditions, including uncontrolled fluid build-up around the lungs or abdomen, uncontrolled diabetes, serious heart rhythm problems, a major heart or stroke event within the past 6 months, significant heart failure, or uncontrolled high blood pressure despite treatment (confirm with trial site for full details).
• People with a history of lung inflammation that required steroid treatment, or a history of scarring lung disease, or a current active lung infection.
• People who have needed intravenous antibiotics or other infection-fighting medications within 1 week before the first dose for an active infection.
• People with active Hepatitis B, Hepatitis C, or syphilis; some exceptions may apply if certain virus levels are below specified thresholds, and people with liver cancer and elevated Hepatitis B virus levels may first need antiviral treatment before being considered (confirm with trial site).
• People with a known history of a primary immune deficiency condition, or a positive HIV test, or other inherited or acquired immune deficiency conditions.
• People who have had another cancer diagnosed within the past 5 years, with some exceptions for cancers treated with curative intent more than 3 years ago with no signs of return, or certain low-risk skin cancers and non-invasive cancers (confirm with trial site).
• People with a history of autoimmune disease within the past 2 years (such as lupus, rheumatoid arthritis, inflammatory bowel disease, and others); some exceptions apply for stable, well-managed conditions such as type 1 diabetes, treated underactive thyroid, or mild skin conditions (confirm with trial site).
• People who have had a serious blood clot event — such as a heart attack, stroke, or unstable chest pain — within the past 6 months, or a deep vein clot or pulmonary embolism within the past 3 months, or who are currently receiving clot-dissolving or blood-thinning therapy for high clotting risk.
• People who have previously received a donor bone marrow or stem cell transplant, or a solid organ transplant (corneal transplant is an exception).
• People who still have unresolved side effects from previous cancer treatments rated above a mild level (grade 1 or higher on a standard scale), with some exceptions for certain lasting effects such as hair loss, skin changes, stable thyroid conditions, or mild nerve symptoms (confirm with trial site).
• People with a known history of a severe allergic reaction (grade 3 or higher) to protein-based medicines or monoclonal antibodies, or to any ingredient in the study drug.
• People with known alcohol or drug dependence, or any other condition that the trial doctors consider would affect safety or the ability to follow the study requirements, including certain psychiatric conditions.
• Women who are pregnant or currently breastfeeding.

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