This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.
The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W)
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W).
Anhui Provincial Cancer Hospital
ORR
Objective response rate(ORR) evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: 2years
DOR
Duration of response (DoR) evaluated based on RECIST v1.1
Time frame: 2years
DCR
Disease control rate (DCR) evaluated based on RECIST v1.1
Time frame: 2years
PFS
Progression-free survival (PFS) evaluated based on RECIST v1.1
Time frame: 2years
OS
The time from first dose to death from any cause
Time frame: 3years
AE
Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v5.0
Time frame: 2years
Plasma concentrations
Plasma concentrations of JS207 and 9MW2821.
Time frame: 2years
ADA
The incidence and titer of anti-drug antibodies (ADA) of JS207 and 9MW2821
Time frame: 2years
Nab
The incidence of Nab(if applicable) of JS207 and 9MW2821
Time frame: 2years
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Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
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The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy
Time frame: 2years
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The correlation between Nectin-4 expression in tumor tissue and therapeutic efficacy
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