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The study is being conducted to evaluate the safety and tolerability of HRS-3005. To explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-3005 in patients with B-cell malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-3005 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3005 | Drug | HRS-3005 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints: Incidence of adverse events (AEs),number of participants with abnormal laboratory test results . | approximately 1 year | |
| MTD(Maximum tolerated dose) | 28 days after treatment initiation | |
| RP2D(Recommended Phase II Dose) | approximately 2 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration (Cmax) | 12 weeks after treatment initiation | |
| Time to Peak Concentration (Tmax) | 12 weeks after treatment initiation; | |
| Area Under the Curve (AUC0-t, AUC0-inf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanyi Zhai | Contact | +86-0518-82342973 | wanyi.zhai.wz5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Hospital of the Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| 12 weeks after treatment initiation; |
| Half-life (t1/2) | 12 weeks after treatment initiation; |
| Apparent Clearance (CL/F) | 12 weeks after treatment initiation; |
| Apparent Volume of Distribution (Vz/F) | 12 weeks after treatment initiation |
| Objective Response Rate (ORR) | approximately 1 year; |
| Time to Response (TTR) | approximately 1 year; |
| Duration of Response (DoR) | approximately 1 year; |
| Progression-Free Survival (PFS) | approximately 1 year; |
| Overall Survival (OS) | approximately 1 year |