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This research study is a multicentre phase â… b/â…¡ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1921 | Experimental | A1:SHR-A1921+Adebrelimab A2:SHR-A1921+Carboplatin A3:SHR-A1921+Cisplatin A4:SHR-A1921+Bevacizumab A5:SHR-A1921+Adebrelimab+Carboplatin A6:SHR-A1921+Adebrelimab+Cisplatin B1:SHR-A1921+Adebrelimab B2:SHR-A1921+Adebrelimab+Carboplatin/Cisplatin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1921ï¼› | Drug | Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as an IV infusion Drug: Bevacizumab administered as an IV infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. (Phase 1b) | up to 21 days of cycle 1 | |
| Determination of Recommended Phase II dose (RP2D) (Phase 1b) | Up to 21 days of cycle 1 | |
| Objective Response Rate as Assessed by the Investigator according to RECIST v1.1(Phase II) | From baseline to progressive disease or death (approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only), | From baseline to progressive disease or death (approximately 1 year)] | |
| Duration of Response as Assessed by the Investigator according to RECIST v1.1 | From baseline to progressive disease or death (approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute& Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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| Disease Control Rate as Assessed by the Investigator according to RECIST v1.1 | From baseline to progressive disease or death (approximately 1 year) |
| Time to Response as Assessed by the Investigator according to RECIST v1.1 | From baseline to progressive disease or death (approximately 1 year) |
| Progression-free Survival as Assessed by the Investigator according to RECIST v1.1 | From baseline to progressive disease or death (approximately 1 year) |
| Overall survival | approximately 12months after last patient enrolled. |