JS207 Combination Therapy in Triple-negative Breast Cancer
ConditionTriple-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female age 18 - 75 years old；
Voluntary participation in clinical study；
Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
Disqualifiers
Untreated or active central nervous system (CNS) metastases；
Uncontrolled pleural effusion, pericardial effusion or ascites；
Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；
History of significant bleeding tendency or severe coagulation disorder；
Trial design
Design model
Parallel
Treatments tested in this trial
JS207 in combination with 9MW2821
DrugJS207 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 in combination with Albumin paclitaxel
DrugJS207 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame
2yearsSecondary outcomes
1
DOR
Duration of response (DoR) evaluated based on RECIST v1.1
Time frame
2years2
DCR
Disease control rate (DCR) evaluated based on RECIST v1.1
Time frame
2years3
PFS
Progression-free survival (PFS) evaluated based on RECIST v1.1
Time frame
2years4
OS
The time from first dose to death from any cause
Time frame
3yearsOther outcomes
1
Nectin-4 expression
The correlation between Nectin-4 expression in tumor tissue and therapeutic efficacy
Time frame
2yearsSponsors and contacts
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Source ClinicalTrials.gov