[Translation] A single-arm, open-label, dose-escalation, and expansion phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SIG001 in patients with advanced solid tumors.
1.主要研究目的: 评估 SIG001 在晚期实体瘤患者中的安全性和耐受性。
2.次要研究目的: 确定 SIG001 的 II 期临床研究推荐剂量(Recommended Phase II dose ,RP2D)。 评 估 SIG001 在 晚 期 实 体 瘤 患 者 中 的 药 代 动 力 学(Pharmacokinetics ,PK)特征。 评 估 SIG001 在 晚 期 实 体 瘤 患 者 中 的 药 效 动 力 学(Pharmacodynamics ,PD)特征。 评估 SIG001 在晚期实体瘤患者中的初步抗肿瘤活性。 评估 SIG001 在晚期实体瘤患者中的免疫原性。
3.探索性目的: 探索 SIG001 的暴露量/剂量与安全性以及临床疗效之间的关系。 探索潜在的生物标记物(如 SIG)的表达水平(如适用),并与药物的暴露量、疗效、安全性进行相关性分析。 探索事件发生时间终点如缓解持续时间(Duration ofresponse,DoR)和无进展生存期(Progression-free survival ,PFS)。
[Translation] 1. Primary Study Objective: To evaluate the safety and tolerability of SIG001 in patients with advanced solid tumors.
2. Secondary Study Objectives: To determine the recommended Phase II dose (RP2D) of SIG001 in a Phase II clinical trial. To evaluate the pharmacokinetic (PK) characteristics of SIG001 in patients with advanced solid tumors. To evaluate the pharmacodynamic (PD) characteristics of SIG001 in patients with advanced solid tumors. To assess the preliminary antitumor activity of SIG001 in patients with advanced solid tumors. To assess the immunogenicity of SIG001 in patients with advanced solid tumors.
3. Exploratory Objective: To explore the relationship between SIG001 exposure/dose and safety and clinical efficacy. Explore the expression levels of potential biomarkers (such as SIG, if applicable) and perform correlation analyses with drug exposure, efficacy, and safety. Explore time endpoints such as duration of response (DoR) and progression-free survival (PFS).