[Translation] A two-stage, open-label, Phase I study of TAVO412 in patients with advanced/metastatic solid tumors who have received prior standard therapy
主要目的:在经标准治疗失败或无标准治疗的晚期 /转移性实体瘤受试者中,评估 TAVO412的安全性、耐受性和剂量限制性毒性( DLT),并确定 TAVO412在晚期或转移性实体瘤受试者中的最大耐受剂量 /推荐第 2阶段剂量( MTD和 /或 RP2D)。
次要目的:评估TAVO412在经标准治疗失败或无标准治疗的晚期或转移性实体瘤受试者中的药代动力学( PK)、免疫原性和药效学( PD)。根据RECIST v1.1,通过评估客观缓解率、疾病控制率、缓解持续时间、PFS和 OS来评估 TAVO412的初步疗效。研究肿瘤生物标志物的变化情况,并初步评估其和疗效之间的相关性。
[Translation] Primary objective: To evaluate the safety, tolerability and dose-limiting toxicity (DLT) of TAVO412 in subjects with advanced/metastatic solid tumors who have failed or have no standard treatment, and to determine the maximum tolerated dose/recommended phase 2 dose (MTD and/or RP2D) of TAVO412 in subjects with advanced or metastatic solid tumors.
Secondary objective: To evaluate the pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of TAVO412 in subjects with advanced or metastatic solid tumors who have failed or have no standard treatment. The preliminary efficacy of TAVO412 was evaluated by evaluating the objective response rate, disease control rate, duration of response, PFS and OS according to RECIST v1.1. To study the changes in tumor biomarkers and preliminarily evaluate their correlation with efficacy.