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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
924
SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab
SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence and severity of AE
Phase 1b
Time frame: Up to follow-up period, approximately 24 months
Dose Limiting Toxicity (DLT)
Phase 1b
Time frame: approximately 24 months
Maximal Tolerable Dose (MTD)
Phase 1b
Time frame: approximately 24 months
Phase III Recommended Dose (RP3D)
Phase 1b
Time frame: approximately 24 months
Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
Phase 3
Time frame: approximately 36 months
SHR-A1904 toxin binding antibody
Phase 1b
Time frame: approximately 24 months
SHR-A1904 Total antibody
Phase 1b
Time frame: approximately 24 months
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Phase 1b
Time frame: approximately 24 months
Expression level of CLDN18.2 in tumor tissues
Phase 1b
Time frame: approximately 24 months
Overall survival (OS)
Phase 3
Time frame: approximately 36 months
Incidence and severity of AE
Phase 3
Time frame: approximately 36 months
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