[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumor activity of ZZ06 in patients with EGFR-positive advanced solid tumors
主要目的是: 评估ZZ06在EGFR阳性晚期实体瘤的成年患者中的安全性和耐受性,包括最大耐受剂量(MTD),并确定II期临床的推荐剂量(RP2D)。
次要目的是: 评估ZZ06单剂后的药代动力学(PK)特性和多剂后稳态特征。 通过检测总抗药抗体包括中和抗体(ADA/Nab)来评估ZZ06的潜在免疫原性。
探索性目的是 根据实体瘤反应评估标准(RECIST)v1.1评估ZZ06抗肿瘤活性。 评估ZZ06对肿瘤标志物的药效学作用(如适用)。
[Translation] The primary objectives are: To evaluate the safety and tolerability of ZZ06 in adult patients with EGFR-positive advanced solid tumors, including the maximum tolerated dose (MTD), and to determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives are: To evaluate the pharmacokinetic (PK) properties of ZZ06 after a single dose and the steady-state characteristics after multiple doses. To evaluate the potential immunogenicity of ZZ06 by detecting total anti-drug antibodies including neutralizing antibodies (ADA/Nab).
Exploratory objectives are to evaluate the anti-tumor activity of ZZ06 according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. To evaluate the pharmacodynamic effects of ZZ06 on tumor markers (if applicable).