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This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-9539 for injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-9539 for injection | Drug | SHR-9539 for dose escalation/dose extension |
|
| Measure | Description | Time Frame |
|---|---|---|
| RP2D of SHR-9539 injection | Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma. | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AE | Assessing the incidence of adverse events (AEs) mainly using the Common Terminology Criteria for Adverse Events (CTCAE Version 5), and CRS and ICANS were graded according to ASTCT standards. | Up to follow-up period, approximately 24 months |
| Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu | Contact | 0518-82342973 | yang.wu.yw96@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Maximum serum concentration |
| Up to follow-up period, approximately 24 months |
| Tmax | Time to reach maximum plasma concentration. | Up to follow-up period, approximately 24 months |
| Overall Response Rate (ORR) | ORR assessed by the IMWG response criteria. | Up to follow-up period, approximately 24 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |