[Translation] Safety, tolerability, pharmacokinetic characteristics and efficacy of XCCS605B in Chinese patients with advanced solid tumors: a multicenter, open-label, single-agent and combination-dose escalation and combination-dose expansion phase I/II clinical trial
单药或联药递增主要目的:评估XCCS605B单药或联合特瑞普利单抗治疗晚期实体瘤患者的安全性和耐受性,并探索XCCS605B单药或联合特瑞普利单抗的最大耐受剂量,确定Ⅱ期推荐剂量(RP2D)。次要目的:评估XCCS605B单药或联合特瑞普利单抗治疗晚期实体瘤患者的PK特征;观察XCCS605B单药或联合特瑞普利单抗治疗晚期实体瘤患者的初步疗效。探索性目的:探索与XCCS605B单药或联合特瑞普利单抗疗效相关的生物标志物。联药扩展主要目的:评估XCCS605B联合特瑞普利单抗治疗外生殖器鳞癌(如肛管癌、阴茎癌、外阴癌等)、小细胞肺癌、食管鳞癌、头颈部鳞癌等晚期实体瘤患者的疗效。次要目的:评估XCCS605B联合特瑞普利单抗治疗外生殖器鳞癌(如肛管癌、阴茎癌、外阴癌等)、小细胞肺癌、食管鳞癌、头颈部鳞癌等晚期实体瘤患者的安全性;评估XCCS605B联合特瑞普利单抗治疗外生殖器鳞癌(如肛管癌、阴茎癌、外阴癌等)、小细胞肺癌、食管鳞癌、头颈部鳞癌等晚期实体瘤患者的PK特征。探索性目的:探索与XCCS605B联合特瑞普利单抗疗效相关的生物标志物。
[Translation] The main purpose of single-drug or combination-drug escalation is to evaluate the safety and tolerability of XCCS605B alone or in combination with toripalimab in the treatment of patients with advanced solid tumors, explore the maximum tolerated dose of XCCS605B alone or in combination with toripalimab, and determine the recommended dose (RP2D) for Phase II. Secondary purpose: to evaluate the PK characteristics of XCCS605B alone or in combination with toripalimab in the treatment of patients with advanced solid tumors; to observe the preliminary efficacy of XCCS605B alone or in combination with toripalimab in the treatment of patients with advanced solid tumors. Exploratory purpose: to explore biomarkers related to the efficacy of XCCS605B alone or in combination with toripalimab. The main purpose of combination-drug expansion is to evaluate the efficacy of XCCS605B combined with toripalimab in the treatment of patients with advanced solid tumors such as squamous cell carcinoma of the external genitalia (such as anal canal cancer, penile cancer, vulvar cancer, etc.), small cell lung cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma. Secondary objectives: To evaluate the safety of XCCS605B combined with toripalimab in the treatment of patients with advanced solid tumors such as squamous cell carcinoma of the genitalia (such as anal canal cancer, penile cancer, vulvar cancer, etc.), small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, etc.; To evaluate the PK characteristics of XCCS605B combined with toripalimab in the treatment of patients with advanced solid tumors such as squamous cell carcinoma of the genitalia (such as anal canal cancer, penile cancer, vulvar cancer, etc.), small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, etc. Exploratory objectives: To explore biomarkers associated with the efficacy of XCCS605B combined with toripalimab.