Clinical Trial of TQB3126 for Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Breast Cancer Subjects
The study includes Phase I dose escalation and expansion and Phase II combination therapy. It uses a multicenter, open-label, non-randomized design to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3126 in breast cancer. Phase I dose escalation uses a Rolling 6 design after accelerated titration at the first dose, with dose decisions reviewed by the Safety Review Committee. Dose expansion includes two cohorts of approximately 20-60 participants each. The study also explores relationships between drug exposure and efficacy/safety, including concentration-QTc