Chengdu Enmu Biotechnology Co., Ltd

Phase I Part Main Objectives: To evaluate the safety, tolerability, maximum tolerated dose (MTD)/recommended Phase II study dose (RP2D) of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. Phase II Part Main Objectives: To evaluate the efficacy of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. Pharmacokinetic (PK) characteristics in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the pharmacodynamic (PD) effects of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the preliminary anti-tumor activity of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the immunogenicity of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. Exploratory Objectives: To explore the relationship between 1A46 exposure and B cell depletion, efficacy and safety. Preliminary exploration of the relationship between pharmacodynamic indicators and efficacy. Explore the impact of anti-drug antibody production on efficacy and safety. Phase II part Main purpose: To evaluate the efficacy of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects.

Primary objectives: To evaluate the safety and tolerability of BR115 injection in patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or phase II clinical recommended dose (RP2D) of BR115 injection. Secondary objectives: (1) To evaluate the preliminary efficacy of BR115 injection in patients with advanced malignant tumors. (2) To evaluate the pharmacokinetic characteristics of BR115 injection in patients with advanced malignant tumors. (3) To evaluate the immunogenicity of BR115 injection. (4) To preliminarily evaluate the correlation between the patient's HER2 expression level and clinical efficacy. (5) If data permit, preliminarily evaluate the correlation between the PK, efficacy and safety of BR115 injection. (6) The data from this study will be included in the PopPK analysis data set, and based on the Pop-PK analysis method, the population PK characteristics of BR115 injection in patients with advanced malignant tumors will be described.