Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-01; most recent amendment 2025-12-25.
Status change: Not Yet Recruiting → Recruiting 2024-04-25
Trial Details
NCT Number NCT06350006
Lead Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions CLDN18.2-positive Advanced Solid Tumor
Enrollment 924 participants
Start Date 2024-05-29
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-31