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This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3276 for Injection will be administrated per dose level in which the patients are assigned. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3276 | Drug | Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | up to 3 years | |
| MTD | up to 6 months | |
| RP2D | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | up to 3 years | |
| Maximum concentration (Cmax) | up to 3 years | |
| Receptor Occupancy(OR) of SHR-3276 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenqun Lu | Contact | +0518-81220121 | zhenqun.lu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of PLA Army Medical University | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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Single arm study of SHR-3276
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| up to 3 years |
| Anti-drug antibody (ADA) of SHR-3276 | up to 3 years |
| Objective response rate (ORR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years |
| Duration of response (DoR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years |
| Disease control rate (DCR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years |
| Progression free survival(PFS) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years |
| Overall survival (OS) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years |