[Translation] An open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BR101 injection as monotherapy in patients with advanced solid tumors
Ⅰa期部分:评价BR101注射液单药(单次给药和多次给药)在晚期实体瘤受试者中的安全性和耐受性,确定最大耐受剂量(MTD)。
Ⅰb期部分:初步探索BR101单药治疗在晚期三阴性乳腺癌及晚期胰腺癌患者中的有效性,确定II期临床试验推荐剂量(RP2D)。
[Translation] Phase Ia part: To evaluate the safety and tolerability of BR101 injection as a single agent (single-dose and multiple-dose) in subjects with advanced solid tumors, and determine the maximum tolerated dose (MTD).
Phase Ib: Preliminarily explore the efficacy of BR101 monotherapy in patients with advanced triple-negative breast cancer and advanced pancreatic cancer, and determine the recommended dose for phase II clinical trials (RP2D).