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:

• People who have given written consent to participate in the study.
• People who have a confirmed diagnosis of advanced stomach or gastroesophageal junction (stomach-oesophagus junction) cancer that cannot be surgically removed, or that has spread to other parts of the body, and who have not yet received treatment for this stage of the disease. People who previously had chemotherapy before or after surgery may also be considered, as long as their cancer came back more than 6 months after that treatment ended.
• People whose cancer has at least one measurable area of disease, as assessed by standard imaging guidelines.
• People whose cancer tests positive for a protein called CLDN 18.2.
• People whose cancer tests negative for a protein called HER2, and whose PD-L1 score (a measure of immune activity in the tumour) is below 5.
• People who are in relatively good general health, able to carry out everyday activities with minimal limitation (as rated on a standard medical scale called ECOG 0–1).
• People who are expected to live for more than 3 months.
• People aged 18 to 75 years.
• People whose blood tests show that their bone marrow, blood clotting, liver, and kidneys are functioning adequately.
• People of childbearing potential who agree to use effective contraception from the time of signing consent until 3 months after the last dose. Women of childbearing potential must have a negative pregnancy blood test within 72 hours before the first dose.

Who may not be able to join:

• People who have had radiotherapy within the 4 weeks before starting the study treatment (an exception may apply if palliative radiotherapy was given only to bone metastases and side effects have resolved — confirm with trial site).
• People who have received any other anti-cancer treatment within 4 weeks before starting the study treatment.
• People who have had major surgery within 4 weeks before starting the study treatment.
• People who have had a serious allergic reaction or intolerance to the study drug M108 or similar antibody-based medicines, or to the chemotherapy drugs capecitabine or oxaliplatin, or their ingredients.
• People who have previously been treated with any therapy that specifically targets the CLDN 18.2 protein, including certain antibodies, cell therapies, or antibody-drug combinations.
• People who are currently pregnant or breastfeeding.
• People who have another significant medical condition that could make it unsafe to receive the treatments used in this study.

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