[Translation] An open-label, phase I trial of LVGN7409 monotherapy in locally advanced, metastatic, or relapsed or refractory malignancies
主要目的: 在局部晚期、转移性或复发难治恶性肿瘤成人受试者中评价LVGN7409单药治疗的安全性、耐受性、MTD、 和/或RDE和/或RP2D。
次要目的: 评估LVGN7409单药的单次给药和多次给药的药代动力学(PK)。 评估LVGN7409单药的初步抗肿瘤活性。根据实体瘤疗效评价标准(RECIST)第1.1版、实体瘤免疫治疗疗效评价标准(iRECIST),采用客观缓解率(ORR)、缓解持续时间(DOR)、疾病控制率(DCR)和无进展生存期(PFS)描述初步抗肿瘤活性。 评估LVGN7409单药的免疫原性。
探索性目的: 评估LVGN7409单药治疗免疫状态的变化。 评估LVGN7409单药治疗药效学生物标志的变化。
[Translation] Main objective: To evaluate the safety, tolerability, MTD, and/or RDE and/or RP2D of LVGN7409 monotherapy in adult subjects with locally advanced, metastatic, or relapsed or refractory malignancies.
Secondary objectives: To evaluate the single- and multiple-dose pharmacokinetics (PK) of LVGN7409 as a single agent. To evaluate the preliminary antitumor activity of LVGN7409 as a single agent. According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival were used (PFS) describes preliminary antitumor activity. To assess the immunogenicity of LVGN7409 as a single agent.
Exploratory Objectives: To assess changes in immune status with LVGN7409 monotherapy. Assessing changes in LVGN7409 monotherapy pharmacodynamic biomarkers.