A Phase 2 interventional study of JS212 in combination with JS207 and JS212 monotherapy in Triple-negative Breast Cancer, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Not yet recruiting at 29 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 2, Interventional, and Treatment
This is an phase II study to prelininarily evaluate the efficacy and safety of JS212 mono therapy or combination therapy in patients with recurrent or metastatic TNBC.
The study consists of 2 parts. Both parts consist of safety run-in period and cohort expansion period. Safety run-in period will enroll those who have received only 1 line of prior systemic standard treatment. Cohort expansion period will enroll those are treated naive or recived treatment in adjuvant phase.
Part 1 will receive JS212 monotherapy or combination therapy with JS207, based on the PD-L1 expression. Part 2 will receive JS212 in combination with JS001.
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's planned enrollment of 184 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 100 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
JS212 in combination with JS207，CPS≥10
Drug: JS212 in combination with JS207
JS212 monotherapy, CPS\<10
Drug: JS212 monotherapy
JS212 in combination with JS207, CPS\<10
Drug: JS212 in combination with JS207
JS212 in combination with JS001
Drug: JS212 in combination with JS001
JS212 and JS207 will be administered intravenously on D1, Q3W
JS212 will be administered intravenously on D1，Q3W
JS212 and JS001 will be administered intravenously on D1, Q3W
Objective response rate（ORR）
Objective response rate（ORR） evaluated based on RECIST v1.1
Time frame: 24 months
Duration of response (DoR)
Duration of response (DoR) evaluated based on RECIST v1.1
Time frame: 24 months
Disease control rate (DOR)
Disease control rate (DOR)evaluated based on RECIST v1.1
Time frame: 24 months
Progression free survival (PFS)
Progression free survival (PFS) evaluated based on RECIST v1.1
Time frame: 24 months
Overall Survival (OS)
Overall Survival (OS)evaluated based on RECIST v1.1
Time frame: 36 months
Adverse Events
Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v6.0
Time frame: 24 months
Immunogenicity
The incidence of Nab(if applicable) of JS212 and JS207
Time frame: 24 months
Plasma concentrations
Plasma concentrations of JS207 and 9MW2821
Time frame: 2 years
PD-L1 expression
The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy
Time frame: 2 years
EGFR/HER expression
The correlation between EGFR/HER3 expression in tumor tissue and therapeutic efficacy
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: JS212
Triple Negative Breast Neoplasms →
Shanghai Junshi Bioscience Co., Ltd. →