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This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4375 Injection in Combination With Other Antitumor Therapies Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4375 Injection | Drug | SHR-4375 injection in combination with other antitumor therapies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT). | 3 weeks. | |
| Recommended phase II dose (RP2D). | From screening period up to study completion, an average of 1 year. | |
| Adverse events (AEs). | From screening period up to study completion, an average of 1 year. | |
| Objective response rate (ORR). | From screening period up to study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | From screening period up to study completion, an average of 1 year. | |
| Duration of response (DoR) | From screening period up to study completion, an average of 1 year. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Jing | Contact | +86-0518-82342973 | yunpeng.jin.yj1@hengrui.com | |
| Hao Shen | Contact | +86-021-61053363 | hao.shen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Progression-free survival (PFS) |
| From screening period up to study completion, an average of 1 year. |
| Drug Resistant Antibody (ADA) to SHR-4375 | Immunogenicity: The number of subjects with ADA to SHR-4375, incidence, time of occurrence, duration, etc. | From screening period up to study completion, an average of 1 year. |