[Translation] A multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of BAT7111 for injection in patients with advanced solid tumors
主要目的:
Ⅰ期研究:
①评估注射用 BAT7111 治疗晚期实体瘤患者的安全性与耐受性;
②探索最大耐受剂量(MTD)并为 II 期或后续临床研究提供推荐剂量(RP2D)及合理的给药方案;
Ⅱ期研究:
· 进一步评估注射用 BAT7111 在晚期实体瘤中的安全性与耐受性,为后续研究确定优化的 RP2D 及给药方案;
· 初步评估注射用 BAT7111 在晚期实体瘤中的初步疗效。
次要目的:
Ⅰ期研究:
①评价注射用BAT7111在晚期实体瘤患者中单次给药和多次给药的药代动力学(PK)特征;
②评价注射用 BAT7111 的免疫原性;
③初步评价注射用 BAT7111 的抗肿瘤疗效;
④初步评价注射用 BAT7111 的药效学特性。
Ⅱ期研究:
· 进一步探索注射用 BAT7111 在晚期实体瘤中的临床疗效;
· 进一步评价注射用 BAT7111 在晚期实体瘤中的单次给药和多次给药的 PK 特征;
· 进一步评价注射用 BAT7111 的免疫原性;
· 评价注射用 BAT7111 的药效学特性
[Translation] Main objectives:
Phase I study:
①Evaluate the safety and tolerability of BAT7111 for injection in the treatment of patients with advanced solid tumors;
②Explore the maximum tolerated dose (MTD) and provide a recommended dose (RP2D) and a reasonable dosing regimen for Phase II or subsequent clinical studies;
Phase II study:
· Further evaluate the safety and tolerability of BAT7111 for injection in advanced solid tumors, and determine the optimized RP2D and dosing regimen for subsequent studies;
· Preliminary evaluation of the preliminary efficacy of BAT7111 for injection in advanced solid tumors.
Secondary objectives:
Phase I study:
①Evaluate the pharmacokinetic (PK) characteristics of single and multiple administrations of BAT7111 for injection in patients with advanced solid tumors;
②Evaluate the immunogenicity of BAT7111 for injection;
③Preliminary evaluation of the anti-tumor efficacy of BAT7111 for injection;
④Preliminary evaluation of the pharmacodynamic properties of BAT7111 for injection.
Phase II study:
· Further explore the clinical efficacy of BAT7111 for injection in advanced solid tumors;
· Further evaluate the PK characteristics of single and multiple administrations of BAT7111 for injection in advanced solid tumors;
· Further evaluate the immunogenicity of BAT7111 for injection;
· Evaluate the pharmacodynamic properties of BAT7111 for injection