[Translation] An open-label, single-arm phase I clinical study: to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SC0191 tablets in patients with advanced malignant solid tumors, and to preliminarily explore the anti-tumor properties of SC0191 tablets active
主要目的:
- 评估SC0191片单药在晚期恶性实体瘤患者中的DLT发生情况(剂量爬坡期);
- 确定SC0191片单药的II期临床推荐剂量(RP2D)(剂量爬坡期);
- 评估SC0191片单药在晚期恶性实体瘤患者中的安全性和耐受性;
次要目的:
- 评估SC0191片单药在晚期恶性实体瘤患者中的药代动力学(PK)特征;
- 评估SC0191片单药在晚期恶性实体瘤患者中的初步抗肿瘤活性。
[Translation] main purpose:
- To evaluate the occurrence of DLT in patients with advanced malignant solid tumors (dose escalation period) as a single agent of SC0191 tablet;
- Determining the recommended dose (RP2D) of SC0191 single-agent Phase II (dose escalation phase);
- To evaluate the safety and tolerability of SC0191 tablet in patients with advanced malignant solid tumors;
Secondary purpose:
- To evaluate the pharmacokinetic (PK) characteristics of SC0191 tablet in patients with advanced malignant solid tumors;
- To evaluate the preliminary antitumor activity of SC0191 tablet in patients with advanced malignant solid tumors.