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This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1912 combined with R-Chemo (Phase 1b) | Experimental |
| |
| SHR-A1912 combined with R-Chemo (Phase 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1912; R-Chemo | Drug | SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy | The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months | |
| Phase 1b: Incidence and severity of AE | Up to follow-up period, approximately 24 months] | |
| Phase 2: Objective response rate | assessed up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Objective response rate | assessed up to approximately 24 months | |
| Phase 1b: Complete response rate (CRR) | assessed up to approximately 24 months | |
| Phase 1b: Duration of remission (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Xiao, Medical Director | Contact | 021-61053363 | zhenyu.xiao.zx7@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | 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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An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
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| SHR-A1912; R-Chemo | Drug | SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2) |
|
| assessed up to approximately 24 months |
| Phase 1b: Progression-free survival (PFS) | assessed up to approximately 24 months |
| Phase 1b: Toxin binding antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 1b: Total antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 1b: Concentration of free toxin | Up to follow-up period, approximately 24 months |
| Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Complete response rate (CRR) | assessed up to approximately 24 months |
| Phase 2: Duration of remission (DoR) | assessed up to approximately 24 months |
| Phase 2: Progression-free survival (PFS) | assessed up to approximately 24 months |
| Phase 2: Incidence and severity of AE | Up to follow-up period, approximately 24 months |
| Phase 2: Toxin binding antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Total antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Concentration of free toxin | Up to follow-up period, approximately 24 months |
| Phase 2: Anti-drug antibodies (ADA) to SHR-A1912 | Up to follow-up period, approximately 24 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |