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This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F0002-ADC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F0002-ADC | Drug | Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD | the maximum tolerable dose | Within 21 days after a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years |
| DOR | Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Henan Cancer Hospital |
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| Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years |
| PFS | Progress Free Survival | Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years |
| Maximum Plasma Concentration [Cmax] | pharmacokinetic parameter | 1 months after last dose |
| Area Under the Curve [AUC] | pharmacokinetic parameter | 1 months after last dose |
| Tmax | pharmacokinetic parameter | 1 months after last dose |
| Half-life Time [T1/2] | pharmacokinetic parameter | 1 months after last dose |
| Clearance [CL] | pharmacokinetic parameter | 1 months after last dose |
| Apparent Volume of Distribution [Vd] | pharmacokinetic parameter | 1 months after last dose |
| Immunogenicity | Anti-F0002-ADC Antibodies | 1 months after last dose |
| Incidence of adverse events | Till 1 month after last dose |
| Incidence of laboratory abnormalities | Till 1 month after last dose |
| Zhengzhou |
| Henan |
| 450008 |
| China |