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This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-7787 combined with SHR-1316 | Experimental | SHR-7787 injection combined with SHR-1316 injection. |
|
| SHR-7787 combined with SHR-4849 | Experimental | SHR-7787 injection combined with SHR-4849 injection. |
|
| SHR-7787 combined with etoposide and carboplatin/cisplatin | Experimental | SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection. |
|
| SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin | Experimental | SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection. |
|
| SHR-7787 combined with SHR-4849 and SHR-1316 | Experimental | SHR-7787 injection combined with SHR-4849 and SHR-1316 injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-7787 Injection | Drug | SHR-7787 Injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Recommended phase II dose of SHR-7787 injection monotherapy (stage I) | Expected to be two years after the start of the study. | |
| Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) | About 1 year after study initiation. | |
| Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) | About 1 year after study initiation. | |
| Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I) | About 1 year after study initiation. | |
| Objective response rate (ORR) (stage II) | Expected to be two years after the start of the study. | |
| Progress Free Survival (FPS) (stage II) | Expected to be two years after the start of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | About 1 year. | |
| Duration of Response (DoR) | About 1 year. | |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianhua Qiu | Contact | +86-0518-82342973 | xianhua.qiu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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|
| SHR-7787 combined with SHR-1316 and BP102 | Experimental | SHR-7787 injection combined with SHR-1316 and BP102 injection. |
|
| SHR-7787 combined with SHR-4849 and BP102 | Experimental | SHR-7787 injection combined with SHR-4849 and BP102 injection. |
|
| SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin | Experimental | SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection. |
|
| SHR-1316 Injection | Drug | SHR-1316 Injection. |
|
| SHR-4849 Injection | Drug | SHR-4849 Injection. |
|
| Etoposide injection | Drug | Etoposide Injection. |
|
| Carboplatin injection | Drug | Carboplatin Injection. |
|
| Cisplatin injection | Drug | Cisplatin Injection. |
|
| BP102 Injection | Drug | BP102 Injection. |
|
| About 1 year. |
| Progress Free Survival (PFS) | About 1 year. |
| Overall Survival (OS) | About 1 year. |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| ID | Term |
|---|---|
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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