[Translation] Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma
主要研究目的
剂量递增阶段:
评估 IBD0333在局部晚期/转移性实体瘤或非霍奇金淋巴瘤受试者中的安全性和耐受性,确定最大耐受剂量(MTD)、扩展推荐剂量(DRDE)和/或剂量限制性毒性(DLT)。
剂量扩展阶段:
评估 IBD0333在局部晚期/转移性实体瘤或非霍奇金淋巴瘤受试者中的安全性和耐受性,确定II期临床研究推荐剂量(RP2D)。
临床探索阶段:
评估 IBD0333在特定瘤种受试者中的初步有效性。
次要研究目的
剂量递增阶段&剂量扩展阶段:
评估IBD0333在局部晚期/转移性实体瘤或非霍奇金淋巴瘤受试者中的药代动力学(PK)特征;
评估IBD0333在局部晚期/转移性实体瘤或非霍奇金淋巴瘤受试者中的免疫原性;
评估 IBD0333在局部晚期/转移性实体瘤或非霍奇金淋巴瘤受试者中的初步有效性。
临床探索阶段:
评估 IBD0333在特定瘤种受试者中的安全性和耐受性;
评估IBD0333在特定瘤种受试者中的免疫原性。
探索性研究目的
探索血液及组织中预测潜在IBD0333疗效的生物标志物。
[Translation] Main study objectives
Dose escalation phase:
Evaluate the safety and tolerability of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma, and determine the maximum tolerated dose (MTD), recommended dose for expansion (DRDE) and/or dose-limiting toxicity (DLT).
Dose expansion phase:
Evaluate the safety and tolerability of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma, and determine the recommended dose for Phase II clinical studies (RP2D).
Clinical exploration phase:
Evaluate the preliminary efficacy of IBD0333 in subjects with specific tumor types.
Secondary study objectives
Dose escalation phase & dose expansion phase:
Evaluate the pharmacokinetic (PK) characteristics of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma;
Evaluate the immunogenicity of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma;
Evaluate the preliminary efficacy of IBD0333 in subjects with locally advanced/metastatic solid tumors or non-Hodgkin's lymphoma.
Clinical Exploration Phase:
Evaluate the safety and tolerability of IBD0333 in subjects with specific tumor types;
Evaluate the immunogenicity of IBD0333 in subjects with specific tumor types.
Purpose of Exploratory Research
Explore biomarkers in blood and tissues that predict the potential efficacy of IBD0333.