Phase 2 Study of JS207 Combined with 9MW2821 or Albumin Paclitaxel for First-Line Treatment of Recurrent or Metastatic Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new combination therapy involving JS207 with either 9MW2821 or albumin paclitaxel as a first treatment option for patients with recurrent or metastatic triple-negative breast cancer TNBC. This phase II, open-label, multi-center study aims to gather preliminary data on these treatments in patients who have not previously received systemic anti-tumor therapy for their advanced cancer. The study includes two groups Cohort A receives JS207 combined with 9MW2821, and Cohort B receives JS207 combined with albumin paclitaxel. Both drug combinations are given intravenously every three weeks, with JS207 dosed at 10 mgkg on day 1. 9MW2821 is administered at 1.25 mgkg on days 1 and 8, while albumin paclitaxel is given at 125 mgm2 on days 1 and 8. Each cohort consists of a safety run-in period followed by an expansion period to further evaluate the treatments. Participants will undergo regular assessments including tumor measurements based on RECIST v1.1 criteria and monitoring for adverse events over two years. Researchers will track outcomes such as overall response rate ORR, duration of response, disease control rate, progression-free survival, and overall survival. Blood samples will be collected to measure drug levels and immune responses. The study spans up to three years, with ongoing safety and efficacy evaluations to help understand these therapies in this patient population.

JS207 Combination Therapy in Triple-negative Breast Cancer