INV-1120在局部晚期/转移性实体瘤患者中的首次人体、开放式、I期(剂量递增)临床试验
主要研究目的 观察INV-1120在实体瘤患者中单药治疗的安全性及耐受性;
确定INV-1120的最大耐受剂量(MTD)和/或推荐II期剂量(RP2D),评估其剂量限制毒性(DLT)。 次要研究目的
评估INV-1120单次给药和多次给药达到稳态后的药代动力学 (PK)特征;
初步评估不同剂量INV-1120在实体瘤患者中的抗肿瘤效应( 以RECIST v1.1标准为依据 ),包括客观缓解率(ORR)、疾病控制率(DCR)、缓解持续时间(DOR)、无进展生存期(PFS)和总生存期(OS)。
A Phase 1a/1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.
100 项与 INV-1120 相关的专利(医药)