This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as an IV infusion Drug: Bevacizumab administered as an IV infusion
Tianjin Medical University Cancer Institute& Hospital
Tianjin, Tianjin Municipality, China
Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. (Phase 1b)
Time frame: up to 21 days of cycle 1
Determination of Recommended Phase II dose (RP2D) (Phase 1b)
Time frame: Up to 21 days of cycle 1
Objective Response Rate as Assessed by the Investigator according to RECIST v1.1(Phase II)
Time frame: From baseline to progressive disease or death (approximately 1 year)
Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only),
Time frame: From baseline to progressive disease or death (approximately 1 year)]
Duration of Response as Assessed by the Investigator according to RECIST v1.1
Time frame: From baseline to progressive disease or death (approximately 1 year)
Disease Control Rate as Assessed by the Investigator according to RECIST v1.1
Time frame: From baseline to progressive disease or death (approximately 1 year)
Time to Response as Assessed by the Investigator according to RECIST v1.1
Time frame: From baseline to progressive disease or death (approximately 1 year)
Progression-free Survival as Assessed by the Investigator according to RECIST v1.1
Time frame: From baseline to progressive disease or death (approximately 1 year)
Overall survival
Time frame: approximately 12months after last patient enrolled.
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