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This study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the combination of SHR-1501 and Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1501, Adebrelimab | Drug | the combination of SHR-1501 and Adebrelimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | evaluate the safety in the doses escalation | 21 Days or 28 days |
| Maximum tolerated dose or Maximum-administered dose | evaluate the safety in the doses escalation | Approximately 1 years |
| Recommended Phase 2 dose (RP2D) | evaluate the safety and curative effect in the doses escalation | Approximately 2years. |
| Objective response rate(ORR) | Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | Preliminary safety of the effectiveness of the combination of SHR-1501 and Adebrelimab | 21 Days,Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of SHR-1501 | To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Time to maximum concentration (Tmax) of SHR-1501 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Qiu | Contact | +0518-81220121 | fei.qiu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab
| Approximately 2 years |
| Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501 | To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Steady-state valley concentration (Cmin)of SHR-1501 | To evaluate the pharmacokinetic characteristics of Steady-state valley concentration | Approximately 2 years |
| Accumulation ratio(Rac) of SHR-1501 | To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Anti-drug antibody of SHR-1501 | To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Duration of response(DoR) | Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Disease control rate (DCR) | Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Progression free survival (PFS ) | Preliminary evaluation of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |
| Overall survival(OS) | Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab | Approximately 2 years |