SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

Inclusion criteria

• Age 18 to 75 years old (including boundary values);
• Volunteer to participate in this clinical study and sign informed consent;
• ECOG score 0-1;
• Expected survival ≥3 months;
• Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
• positive CLDN18.2 expression in tumor tissue;
• There is at least one measurable lesion that meets the RECIST 1.1 criteria;
• Adequate bone marrow and organ function.

Exclusion criteria

• Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
• HER2 expression in tumor tissue is positive.
• The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
• Has ≥ grade 2 peripheral sensory neuropathy.
• Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
• Has a history or current history of meningeal metastasis; or active brain metastases.
• Presence of dysphagia or other factors affecting the use of oral medications.
• Additional malignancy within the five years prior to the first administration or randomization.
• Has an active autoimmune disease or a history of autoimmune disease.
• Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.
• Has a history of clinically significant lung disease.
• Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
• There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.
• A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
• People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
• Has severe cardiovascular and cerebrovascular diseases.
• Gastrointestinal perforation and/or gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.
• In the investigator's judgment, the subject has other factors that could have affected the study results or led to the forced termination of the study.