Phase II Trial Evaluating AK146D1 Alone or with AK112 for Safety and Tumor Response in Advanced Breast Cancer Patients Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety, tolerability, antitumor effects, pharmacokinetics, and immune response of combining two drugs, AK146D1 and AK112, in patients with advanced breast cancer. This Phase II study focuses on patients aged 18 to 75 years with HER2-negative locally advanced, recurrent, or metastatic breast cancer who are not candidates for curative surgery. The trial aims to understand how these treatments work together and their impact on tumor response. Participants are assigned to one of two groups one receives both AK146D1 and AK112 through intravenous infusions, while the other group receives only AK146D1 by intravenous infusion. The study uses a sequential design, with treatments given under medical supervision following specific dosing protocols. The safety run-in phase monitors dose-limiting toxicities during the first three weeks. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, blood tests to measure drug levels and immune responses, and monitoring for any adverse events from the time of consent until up to 90 days after the last dose. Researchers will evaluate outcomes such as objective response rate, progression-free survival, disease control rate, duration and time to response, and overall survival for up to approximately two years. The study includes ongoing safety monitoring and follow-up to assess treatment effects and participant well-being.

A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer