This study was an open-label phase Ⅱ 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
340
anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody
Immune checkpoint inhibitors
anti-PD-1 and anti-HER2 bispecifc antibody
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR)
The primary efficacy end point
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events
The primary safety end point
Time frame: 12 months
Severity of Treatment-Emergent Adverse Events
The primary safety end point
Time frame: 12 months
Progression-Free-Survival (PFS)
The secondary efficacy end point
Time frame: 24 months
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