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The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3079 Group | Experimental | SHR-3079. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3079 Injection | Drug | SHR-3079 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity (DLT) | 28 days after treatment initiation. | |
| Maximum tolerated dose (MTD) | Approximately 1 year. | |
| Recommended Phase II Dose (RP2D) | Approximately 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Types, incidence and severity of Adverse events (AEs) | Safety endpoints. | Approximately 1 year. |
| Serious adverse events (SAEs) | Safety endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Ji, M.M | Contact | +86-0518-82342973 | wei.ji.wj10@hengrui.com |
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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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SHR-3079 Monotherapy.
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| Approximately 1 year. |
| Peak concentration (Cmax) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Time to peak concentration (Tmax) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Area under the curve (AUC0-t, AUC0-inf) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Half-life (t1/2) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Apparent clearance (CL/F) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Apparent volume of distribution (Vz/F) | Pharmacokinetics (PK) Parameters. | Approximately 1 year. |
| Objective Response Rate (ORR) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Best Overall Efficacy(BOR) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Time to Response (TTR) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Duration of Response (DoR) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Progression-Free Survival (PFS) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Overall Survival (OS) | Preliminary efficacy endpoints. | Approximately 1 year. |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |