Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)

Summary

This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously treated with first-line or second-line systems. It is planned to enroll 78 subjects in this study. Subjects who meet the inclusion and exclusion criteria are divided into a random ratio of 1:1. The experimental group will receive QL1706 in combination with platinum chemotherapy selected by the investigator, and the control group will receive platinum chemotherapy selected by the investigator. A treatment cycle will be held every 3 weeks until disease progression or intolerable toxicity occurs. After subjects in the control group withdraw from the study, they are allowed to receive other treatments selected by the QL1706 co-investigators based on the subjects 'wishes. Efficacy assessments will be conducted every 6 weeks (42 days ±7 days) after treatment until disease progression, withdrawal of informed consent, death, or start of new antitumor therapy, whichever comes first.

Timeline

Start

2026-02-10

Primary completion

2029-02-10

Completion

2029-02-10

Drugs

Indications