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Adjustment of R&D strategy
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To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT),recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1802+camrelizumab + famitinib | Drug | SHR-1802 for injection,q3w; Camrelizumab for injection, q3w; Famitinib malate capsules, qd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | 4 weeks | |
| Recommended phase II dose (RP2D) | up to 1 years | |
| ORR | Objective Response Rate, determined according to RECIST v1.1 criteria | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Response, determined according to RECIST v1.1 criteria | up to 2 years |
| DCR | Disease Control Rate, determined according to RECIST v1.1 criteria |
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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 | 300202 | China |
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| ID | Term |
|---|---|
| C584390 | famitinib |
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Dose-escalation: Traditional 3+3 dose-escalation design. Dose-expansion: 10 to 12 subjects (included subjects of the dose-escalation part) will be enrolled in each tolerable dose level.
Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
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| up to 2 years |
| PFS assessed by investigator | Progression Free Survival, determined according to RECIST v1.1 criteria | up to 2 years |
| TTR | Time to Response,determined according to RECIST v1.1 criteria | up to 2 years |
| OS (overall survival) | From date of treatment start to any cause death or last follow-up | up to 2 years |
| 12-month OS rate | from the date of the first dose up to 2 years |
| AEs+SAEs | Adverse Events and Serious Adverse Events assessed by CTCAE v5.0 | from the first drug administration to within 90 days for the last drug dose |
| Concentration of drug in serum | Serum concentration of Camrelizumab for Injection and SHR-1802 for injection. | 0.5 hour before the first dose up to 30 days after last dose |
| Concentration of drug in plasma | Plasma concentration of Famitinib malate capsule and its metabolite. | n the second cycle,predose 1 hour and 6 hours post-dose;In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10,predose 1 hour(each cycle is 21 days) |
| Count of T lymphocyte subsets | Count of CD4+ T lymphocyte subsets in peripheral blood;Count of CD8+ T lymphocyte subsets in peripheral blood. | 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection |
| Percentage of T lymphocyte subsets | Percentage of CD4+ T lymphocyte subsets in peripheral blood;Percentage of CD8+ T lymphocyte subsets in peripheral blood. | 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection |
| ADA | Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection | up to 30 days after last dose |
| Nab | Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection. | up to 30 days after last dose |