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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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
[Translation] A first-in-human, open-label, Phase I (dose-escalation) clinical trial of INV-1120 in patients with locally advanced/metastatic solid tumors
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)。
[Translation] Primary study objectives To observe the safety and tolerability of INV-1120 as a monotherapy in patients with solid tumors;
Determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of INV-1120, and evaluate its dose-limiting toxicity (DLT). Secondary study objectives
Evaluate the pharmacokinetic (PK) characteristics of INV-1120 after single and multiple administrations to reach steady state;
Preliminary evaluation of the anti-tumor effects of different doses of INV-1120 in patients with solid tumors (based on RECIST v1.1 criteria), including objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS).
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