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To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-B208 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-B208 | Drug | ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events | 2 years | |
| The types, severity and incidence of dose-limiting toxicity (DLT) | 1 year | |
| The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD) | 1 year | |
| Objective response rate (ORR) by researchers | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 1 year | |
| Time to Maximum Plasma Concentration (Tmax) | 1 year | |
| Half-life (T1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aixia Lu | Contact | 010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| 1 year |
| Area under the concentration-time curve from zero time to infinity (AUC0-∞) | 1 year |
| Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t) | 1 year |
| Apparent Clearance(CL/F) | 1 year |
| Terminal Apparent Volume of Distribution (Vz/F) | 1 year |
| The ORR evaluated by the researchers | 2 years |
| The Disease Control Rate (DCR) evaluated by the researchers | 2 years |
| The Duration of Response (DOR) evaluated by the researchers | 2 years |
| The Progression-Free Survival (PFS) evaluated by the researchers | 2 years |
| The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers | 2 years |
| The Overall Survival (OS) evaluated by the researchers | 2 years |
| Number of participants with anti-drug antibodies (ADA) to ICP-B208 | 1 year |