[Translation] An open, multicenter, multi-cohort Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FTL008.16 in patients with advanced solid tumors
主要目的:评价 FTL008.16 在晚期实体瘤患者中的安全性、耐受性、最大耐受剂量(MTD)和/或推荐扩展剂量(RDE)和 II 期研究推荐剂量(RP2D)。
次要目的:
1)初步评价 FTL008.16 在晚期实体瘤患者中的抗肿瘤活性。根据RECIST 第 1.1 版、iRECIST 标准,采用 ORR、DOR、DCR 和 PFS等描述初步抗肿瘤活性。
2) 评价 FTL008.16 在晚期实体瘤患者中的药代动力学(PK)特征。
3)评价 FTL008.16 在晚期实体瘤患者中的免疫原性。
探索目的:
1)探索 FTL008.16 的药效学特征。
2)探索相关生物标志物与抗肿瘤疗效的关系。
3)探索 FTL008.16 的药物暴露-效应(安全性和/或有效性)的关系(如数据允许)。
[Translation] Primary objective: To evaluate the safety, tolerability, maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and recommended dose for phase II study (RP2D) of FTL008.16 in patients with advanced solid tumors.
Secondary objectives:
1) To preliminarily evaluate the anti-tumor activity of FTL008.16 in patients with advanced solid tumors. According to RECIST version 1.1 and iRECIST criteria, ORR, DOR, DCR and PFS were used to describe the preliminary anti-tumor activity.
2) To evaluate the pharmacokinetic (PK) characteristics of FTL008.16 in patients with advanced solid tumors.
3) To evaluate the immunogenicity of FTL008.16 in patients with advanced solid tumors.
Exploration objectives:
1) To explore the pharmacodynamic characteristics of FTL008.16.
2) To explore the relationship between relevant biomarkers and anti-tumor efficacy.
3) Explore the drug exposure-effect (safety and/or efficacy) relationship of FTL008.16 (if data permit).