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The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1635 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1635 | Drug | HRS-1635 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events. | approximately 2 year | |
| DLT(Dose-limiting toxicity) | approximately 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration (Cmax) | 15 weeks after treatment initiation | |
| Area Under the Curve (AUC0-t, AUC0-inf) | 15 weeks after treatment initiation | |
| Half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Hu | Contact | +86-0518-82342973 | bin.hu5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | Sichuan | 610041 | China |
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| 15 weeks after treatment initiation |
| Apparent Clearance (CL/F) | 15 weeks after treatment initiation |
| Apparent Volume of Distribution (Vz/F) | 15 weeks after treatment initiation. |
| Relative bioavaliability of HRS-1635 in the fed versus fasted state. | 48 hours post-dose |
| Objective Response Rate (ORR) | approximately 2 year |
| Time to Response (TTR) | approximately 2 year |
| Duration of Response (DoR) | approximately 2 year |
| Progression-Free Survival (PFS) | approximately 2 year |
| Overall Survival (OS) | approximately 2 year |
| Time to Peak Concentration (Tmax) | 15 weeks after treatment initiation |