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Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Queue A | Experimental |
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| Queue B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FH-006 | Drug | Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT: 21or28 days after the first administration of each subject | 21or28 days after the first administration of each subject | |
| AE: from Day1 to 30 days after last dose | from Day1 to 30 days after last dose | |
| Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose | from Day1 to 30 days after last dose | |
| MTD or MAD: 21 or 28 days after the first dose of medication for each subject on dose escalation stage | 21 or 28 days after the first dose of medication for each subject on dose escalation stage | |
| RP2D:Obtain two treatment evaluation data for the last subject during the dose expansion phase | Obtain two treatment evaluation data for the last subject during the dose expansion phase |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenic indicators: anti-FH-006 antibody (ADA) | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxue Pi | Contact | 0518-82342973 | Xiaoxue.pi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| FH-006 | Drug | administered once every 3 weeks (Q3W), with a treatment period of 21 days |
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