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To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | SHR-A1912 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1912 | Drug | SHR-A1912, dose escalation and expansion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 21 Days after the 1st dosing (first cycle) | |
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) | |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) | |
| Recommended phase II dose (RP2D) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 12 weeks after the last dose | |
| Time of maximum observed plasma concentration (Tmax) of SHR-1912 | 21 days after last dose | |
| Maximum observed plasma concentration (Cmax) of SHR-1912 |
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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 |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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single arm for SHR-A1912
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| 21 days after last dose |
| Area under the plasma concentration time curve (AUC) of SHR-1912 | 21 days after last dose |
| Anti-drug antibody (ADA) of SHR-A1912 | 12 weeks after last dose |
| Complete Response Rate (CR) | Up to approximately 2 years |
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Duration of Response (DoR) | Up to approximately 2 years |
| Disease Control Rate (DCR) | Up to approximately 2 years |
| Progression-Free Survival (PFS) | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 3 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |