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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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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