SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
Trial Parameters
Brief Summary
This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study. Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years old (including boundary values); 2. Volunteer to participate in this clinical study and sign informed consent; 3. ECOG score 0-1; 4. Expected survival ≥3 months; 5. Pathologically confirmed locally advanced unresectable or metastatic solid tumors; 6. positive CLDN18.2 expression in tumor tissue; 7. There is at least one measurable lesion that meets the RECIST 1.1 criteria; 8. Adequate bone marrow and organ function. Exclusion Criteria: 1. 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 diagno