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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma.
The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 + SHR6390 | Experimental | SHR-1210 was administered 200mg iv every 2 weeks in combination with SHR6390 150mg or 100mg oral daily with 3 weeks on and 1 week off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 was administered 200mg iv every 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MTD /DLT (phase Ib) | Maximum Tolerated Dose/Dose Limiting Toxicity | Within four weeks after dosing |
| ORR(phase II) | Overall Response Rate | from the first drug administration up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(phase Ib) | Overall Response Rate | from the first drug administration up to two years |
| Incidence of Treatment-Emergent Adverse Events (phase Ib/II) | adverse events/serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqiao Zhang, PhD | Contact | 138 4512 0210 | yanqiaozhang@126.com | |
| Guangyu Wang, PhD | Contact | 18249038966 | 18249038966@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanqiao Zhang, PhD | Harbin Medical University Cancer Hosptital | Principal Investigator |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| SHR6390 |
| Drug |
SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off |
|
| from the first drug administration to within 90 days for the last SHR-1210 dose |
| CBR (phase Ib/II) | Clinical Benefit Rate | from the first drug administration up to last patients treatment for 6 months. |
| DoR (phase Ib/II) | Duration of response | from the first drug administration up to two years |
| PFS(phase Ib/II) | Progression-Free-Survival | from the first drug administration up to two years |
| TTR(phase Ib/II) | Time to Response | from the first drug administration up to one year |
| 12m-OS | 12 months Overall survival | 12 months after the first drug administration |