NCT06350006

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

A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 924 (estimated)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CLDN18.2-positive Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SHR-A1904; Adebrelimab	SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab
DRUG	SHR-A1904; CAPOX; Adebrelimab	SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)

Timeline

• Start date: 2024-05-29
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2024-04-05
• Last updated: 2025-12-31

Locations

1 site across 1 country: China