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This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FH-006 Group | Experimental | FH-006 for injection monotherapy should be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FH-006 for Injection | Drug | FH-006 for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors. | Assessed up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | Up to 2 years. | |
| Maximum concentration (Cmax) | Up to 2 years. | |
| Terminal half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenqun Lu | Contact | +86-0518-81220121 | zhenqun.lu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China | ||
| Tianjin Medical Unversity Cancer Institute & Hospital |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Up to 2 years. |
| Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t) | Up to 2 years. |
| Adverse events (AEs) | Up to 24 weeks. |
| Serious adverse events (SAEs) | Up to 24 weeks. |
| Tianjin |
| Tianjin Municipality |
| 300181 |
| China |
|