[Translation] An open-label, dose-escalation phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetics of Pt(0506)101 for injection in the treatment of advanced malignant solid tumors
1、主要目的 (1)评估注射用Pt(0506)101在晚期恶性实体瘤患者的安全性和耐受性。 (2)评估注射用Pt(0506)101在晚期恶性实体瘤患者中单次给药和多次给药过程中的药代动力学特征。 2、次要目的 (1) 通过客观指标初步评估注射用Pt(0506)101的抗肿瘤疗效。 (2) 为II期临床试验方案提供剂量选择依据。
[Translation] 1. Primary objectives (1) To evaluate the safety and tolerability of Pt(0506)101 for injection in patients with advanced malignant solid tumors. (2) To evaluate the pharmacokinetic characteristics of Pt(0506)101 for injection in patients with advanced malignant solid tumors after single and multiple administrations. 2. Secondary objectives (1) To preliminarily evaluate the anti-tumor efficacy of Pt(0506)101 for injection through objective indicators. (2) To provide a basis for dose selection for the Phase II clinical trial program.