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This study was an open-label phase â…¡ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.
This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | advanced gastric cancer and breast cancer that have failed standard treatment |
|
| Part 2 | Experimental | previously untreated advanced gastric cancer and lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-705 | Drug | anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The primary efficacy end point | 12 months |
| Incidence of Treatment-Emergent Adverse Events | The primary safety end point | 12 months |
| Severity of Treatment-Emergent Adverse Events | The primary safety end point | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival (PFS) | The secondary efficacy end point | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieer Ying, M.D | Contact | 86-13858195803 | hzyingjieer@163.com | |
| Meifang Zheng, M.D. | Contact | 86-15258894828 | 794998553@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| PD-1/L1 inhibitor combined with chemotherapy | Drug | Immune checkpoint inhibitors |
|
| SSGJ-705 combined with chemotherapy | Drug | anti-PD-1 and anti-HER2 bispecifc antibody |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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