Not provided
Not provided
Not provided
Not provided
Not provided
Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Akeso Pharmaceuticals, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | AK104,6 mg/kg IV,every 2 weeks (Q2W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1 | Up to 2 years |
| Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) | OS is defined as the time from the start of treatment with AK104 until death due to any cause. | Up to 2 years |
| Adverse events (AEs) | Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0 | From first dose of AK104 through to 90 days after last dose of AK104 |
| Observed pharmacokinetics (PK) exposure of AK104 | The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration. | From first dose of AK104 through to 90 days after last dose of AK104 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable ADAs. | From first dose of AK104 through to 90 days after last dose of AK104 |