NCT07045311

JS207 Combination Therapy in Triple-negative Breast Cancer

JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	JS207 in combination with 9MW2821	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)
DRUG	JS207 in combination with Albumin paclitaxel	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).

Timeline

• Start date: 2025-09-17
• Primary completion: 2028-03-22
• Completion: 2029-03-22
• First posted: 2025-07-01
• Last updated: 2026-04-15

Locations

22 sites across 1 country: China