[Translation] An open-label, dose-escalation, multicenter Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of XKH002 in the treatment of patients with advanced solid tumors
主要目的:
1. 确定XKH002治疗实体瘤患者的最大耐受剂量(MTD)或最大给药剂量(MAD),并确认扩展期推荐剂量(RDE);
2. 评估XKH002在实体瘤患者中的安全性和耐受性。
次要目的:
1. 评估XKH002的药代动力学(PK)特征;
2. 评估XKH002的抗肿瘤疗效;
3. 评估XKH002的免疫原性。
探索目的:
1. 评估XKH002治疗前可溶性B7-H4及TNF-α、IFN-γ、IL-6、IL-8等其他肿瘤免疫相关因子的含量与疗效关系及治疗前后血清中含量变化;
2. 评估B7-H4、PD-L1及CD8表达水平与疗效的相关性。
[Translation] Main objectives:
1. Determine the maximum tolerated dose (MTD) or maximum dose (MAD) of XKH002 for the treatment of patients with solid tumors, and confirm the recommended dose (RDE) for the extension phase;
2. Evaluate the safety and tolerability of XKH002 in patients with solid tumors.
Secondary objectives:
1. Evaluate the pharmacokinetic (PK) characteristics of XKH002;
2. Evaluate the anti-tumor efficacy of XKH002;
3. Evaluate the immunogenicity of XKH002.
Exploratory objectives:
1. Evaluate the relationship between the content of soluble B7-H4 and other tumor immune-related factors such as TNF-α, IFN-γ, IL-6, IL-8 and the efficacy before XKH002 treatment, as well as the changes in serum content before and after treatment;
2. Evaluate the correlation between the expression levels of B7-H4, PD-L1 and CD8 and the efficacy.