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This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4298 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4298 Injection | Drug | SHR-4298 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs). | Approximately 18 months. | |
| Incidence and severity of serious adverse events (SAEs). | Approximately 18 months. | |
| Maximum Tolerated Dose (MTD). | Approximately 18 months. | |
| Maximum Applicable Dose (MAD). | Approximately 18 months. | |
| Recommended Phase 2 Dose (RP2D). | Approximately 18 months. | |
| Dose-limiting toxicity (DLT). | Approximately 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR). | Approximately 18 months. | |
| Duration of response (DoR). | Approximately 18 months. | |
| Disease control rate (DCR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lulu Yang | Contact | +86-0518-82342973 | lulu.yang.ly103@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510032 | China |
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| Approximately 18 months. |
| Progression-free survival (PFS). | Approximately 18 months. |
| Overall survival (OS). | Approximately 5 years after the last subject enrolled. |