[Translation] Phase Ib study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combination therapy in subjects with advanced malignancies
1、主要目的:
(1)评估IBI363联合治疗在晚期恶性肿瘤受试者中的安全性和耐受性;
(2)评估IBI363联合治疗在晚期恶性肿瘤受试者中的抗肿瘤活性。
2、次要目的:
(1)评估IBI363联合治疗在晚期恶性肿瘤受试者中的药代动力学(Pharmacokinetics, PK)特征;
(2)评估IBI363联合治疗在晚期恶性肿瘤受试者中的免疫原性。
3、探索性目的:
(1)探索肿瘤组织样本中PD-L1表达水平和肿瘤微环境与疗效的关系。
(2)探索IBI363联合治疗在晚期恶性肿瘤受试者中的药效动力学(Pharmacodynamics, PD)特征。
[Translation] 1. Primary objectives:
(1) To evaluate the safety and tolerability of IBI363 combination therapy in subjects with advanced malignant tumors;
(2) To evaluate the anti-tumor activity of IBI363 combination therapy in subjects with advanced malignant tumors.
2. Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of IBI363 combination therapy in subjects with advanced malignant tumors;
(2) To evaluate the immunogenicity of IBI363 combination therapy in subjects with advanced malignant tumors.
3. Exploratory objectives:
(1) To explore the relationship between PD-L1 expression level and tumor microenvironment in tumor tissue samples and efficacy.
(2) To explore the pharmacodynamic (PD) characteristics of IBI363 combination therapy in subjects with advanced malignant tumors.