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During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-723 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-723 | Drug | 3+3 dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity | through study completion, an average of 1.5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) determined using RECIST 1.1 criteria. | Through study completion, an average of 4 years | |
| Disease control rate (DCR) determined using RECIST 1.1 criteria. | Through study completion, an average of 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang | University of Kansas Medical / Cancer Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical / Cancer Centers | Kansas City | Kansas | 66506 | United States | ||
| NYU-Langone Medical Center |
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| Peak concentration (Cmax) | Through study completion, an average of 4 years |
| Time to reach peak concentration (Tmax) | Through study completion, an average of 4 years |
| Half-life (t1/2) | Through study completion, an average of 4 years |
| Area under the plasma concentration-time curve (AUC0-∞ and 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 |
| New York |
| New York |
| 10016 |
| United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |