Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in patients with advanced HER2-Expressing Solid Tumors.
This study includes 2 Parts: Part 1 (SSGJ-705 Plus SSGJ-612 for advanced cancer that have failed standard treatment), and Part 2 (SSGJ-705 or SSGJ-705 Plus SSGJ-612 in combination with chemotherapy for previously untreated advanced gastric cancer).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | advanced cancer that have failed standard treatment |
|
| Part 2 | Experimental | previously untreated advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-705 | Drug | anti-PD-1 and anti-HER2 bispecifc antibody |
| |
| SSGJ-612 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieer Ying, M.D. | Contact | +86-13858195803 | hzyingjieer@163.com | |
| Meifang Zheng, M.D. | Contact | +86-15258894828 | 794998553@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
anti-HER2 antibody |
|
| SSGJ-705 combined with chemotherapy | Drug | SSGJ-705 combined with chemotherapy |
|