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This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1826 | Experimental | Dose escalation; Dose expansion; Therapeutic effect expansion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1826 | Drug | dose is calculated based on the subjects' baseline weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | evaluate the safety in the doses escalation | 21 Days |
| Maximum tolerated dose or Maximum-administered dose | evaluate the safety in the doses escalation | Approximately 1 year |
| Recommended Phase 2 dose (RP2D) | evaluate the safety and curative effect in the doses escalation | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Time to maximum concentration (Tmax) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijun Jia | Contact | +0518-81220121 | yijun.jia@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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| Approximately 2 years |
| Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Half-life (t1/2) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Mean retention times (MRT) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Clearance rate (CL) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Volume of distribution at the steady state (Vss) of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Anti-drug antibody of SHR-1826 | To evaluate the pharmacokinetic characteristics of SHR-1826 | Approximately 2 years |
| Objective response rate (ORR) | Preliminary evaluation of the effectiveness of SHR-1826 | Approximately 2 years |
| Duration of response (DoR) | Preliminary evaluation of the effectiveness of SHR-1826 | Approximately 2 years |
| Disease control rate (DCR) | Preliminary evaluation of the effectiveness of SHR-1826 | Approximately 2 years |
| Progression free survival (PFS) | Preliminary evaluation of the effectiveness of SHR-1826 | Approximately 2 years |
| Overall survival (OS) | Preliminary evaluation of the effectiveness of SHR-1826 | Approximately 2 years |