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| Name | Class |
|---|---|
| CStone Pharmaceuticals | INDUSTRY |
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This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholangiocarcinoma | Experimental | Cholangiocarcinoma |
|
| Squamous cell carcinoma of the head and neck | Experimental | Squamous cell carcinoma of the head and neck(HNSCC) |
|
| Endometrial cancer | Experimental | Endometrial cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib | Drug | dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From the day of first dose to 21 days after last dose | |
| To determine the dose limiting toxicity (DLT) | In the dose escalation part, from the day of first dose to 21 days after last dose | |
| To determine the maximum tolerated dose(MTD) | In the dose escalation part, from the day of first dose to 21 days after last dose | |
| To determine the recommended dose of phase II | In the dose escalation part, from the day of first dose to 21 days after last dose | |
| Objective response rate as determined by the Invertigator using RECIST V1.1 | In the dose escalation part, from the day of first dose to 21 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CS1001 antibody | From the day of first dose to 21 days after last dose | |
| Objective response rate (ORR) | From the day of first dose to 21 days after last dose | |
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Inclusion Criteria:
Phase I study:
subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Guo, MD | Contact | 13501678472 | pattrickguo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Guo, MD | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eastern Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C000710249 | donafenib |
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|
| CS1001 | Drug | CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days |
|
| Overall survival(OS) |
| From the day of first dose to 21 days after last dose |
| Progression free survival(PFS) | From the day of first dose to 21 days after last dose |
| Duration of remission (DOR) | From the day of first dose to 21 days after last dose |