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A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-723 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-723 | Drug | ICP-723 tablet administered orally，once a day，for every 28 days as one cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The objective response rate (ORR) evaluated by the Independent Center Review | Through study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed by the investigator | Through study completion, an average of 4 years | |
| DCR as assessed by the investigator and the IRC | Through study completion, an average of 4 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Colony-stimulating factor (CSF) concentrations | Through study completion, an average of 4 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu | Contact | 020-87343333 | xurh@sysucc.org.cn | |
| Yuhong Li | Contact | liyh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Time to response (TTR) as assessed by the investigator and the IRC |
| Through study completion, an average of 4 years |
| Duration of response (DOR) as assessed by the investigator and the IRC | Through study completion, an average of 4 years |
| Progression-free survival (PFS) as assessed by the investigator and the IRC | Through study completion, an average of 4 years |
| Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC | Through study completion, an average of 4 years |
| central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC | Through study completion, an average of 4 years |
| Overall survival (OS) | Through study completion, an average of 4 years |
| The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria | Through study completion, an average of 4 years |
| The maximum plasma concentration observed (Cmax) | Through study completion, an average of 4 years |
| Time of maximum observed plasma concentration (Tmax) | Through study completion, an average of 4 years |
| Elimination half-life (t1/2) | Through study completion, an average of 4 years |
| AUC0-∞ | Through study completion, an average of 4 years |
| AUC0-t | Through study completion, an average of 4 years |
| Apparent clearance (CL/F) | Through study completion, an average of 4 years |
| Apparent volume of distribution (Vz/F) | Through study completion, an average of 4 years |