[Translation] An exploratory clinical study to evaluate the tolerability, pharmacokinetic and pharmacodynamic characteristics and preliminary efficacy of BC006 monoclonal antibody injection in patients with advanced solid tumors including tenosynovial giant cell tumors
主要目的
剂量递增阶段:
评价BC006单抗注射液治疗晚期实体瘤包括腱鞘巨细胞瘤患者的安全性和耐受性,并探索最大耐受剂量(MTD),确定临床试验推荐剂量(RP2D)。
剂量扩展阶段:
探索BC006单抗注射液治疗晚期实体瘤包括腱鞘巨细胞瘤患者的的安全性和耐受性。评价不同瘤种受试者的客观缓解率(ORR)。
次要目的
(1)评价BC006单抗注射液的药代动力学(PK)和药效动力学(PD)特征。
(2)评价免疫原性特征。
(3)分析受试者的疾病控制率(DCR)、无进展生存期(PFS)等,评价BC006单抗注射液在不同瘤种中的有效性。
[Translation] Main purpose
Dose escalation phase:
To evaluate the safety and tolerability of BC006 monoclonal antibody injection in the treatment of patients with advanced solid tumors including tenosynovial giant cell tumors, explore the maximum tolerated dose (MTD), and determine the recommended dose (RP2D) for clinical trials.
Dose expansion phase:
To explore the safety and tolerability of BC006 monoclonal antibody injection in the treatment of patients with advanced solid tumors including tenosynovial giant cell tumors. To evaluate the objective response rate (ORR) of subjects with different tumor types.
Secondary objectives
(1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of BC006 monoclonal antibody injection.
(2) To evaluate the immunogenicity characteristics.
(3) To analyze the disease control rate (DCR), progression-free survival (PFS) of the subjects, and to evaluate the effectiveness of BC006 monoclonal antibody injection in different tumor types.