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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1904 combined with Adebrelimab | Experimental | SHR-A1904+ Adebrelimab |
|
| SHR-A1904 combined with CAPOX and Adebrelimab | Experimental | SHR-A1904+ CAPOX+ Adebrelimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1904; Adebrelimab | Drug | SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AE | Phase 1b | Up to follow-up period, approximately 24 months |
| Dose Limiting Toxicity (DLT) | Phase 1b | approximately 24 months |
| Maximal Tolerable Dose (MTD) | Phase 1b | approximately 24 months |
| Phase III Recommended Dose (RP3D) | Phase 1b | approximately 24 months |
| Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria | Phase 3 | approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| SHR-A1904 toxin binding antibody | Phase 1b | approximately 24 months |
| SHR-A1904 Total antibody | Phase 1b | approximately 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Shi | Contact | 0518-82342973 | qi.shi.qs16@hengrui.com | |
| Di Zong | Contact | 0518-82342973 | di.zong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two stages, IB-A for dose escalation and IB-B for efficacy expansion. The Phase III multi-center, randomized ,active-controlled, Open-label study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients.
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| SHR-A1904; CAPOX; Adebrelimab | Drug | SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin) |
|
| Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb) | Phase 1b | approximately 24 months |
| Expression level of CLDN18.2 in tumor tissues | Phase 1b | approximately 24 months |
| Overall survival (OS) | Phase 3 | approximately 36 months |
| Incidence and severity of AE | Phase 3 | approximately 36 months |