[Translation] A single-arm, open-label, multicenter, phase II clinical study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency
1、主要研究目的:
评估 CVL237 片在 PTEN 缺失的晚期实体瘤患者中的初步有效性。
2、次要研究目的:
(1) 评估 CVL237 在 PTEN 缺失的晚期实体瘤患者中的安全性;
(2) 评估 CVL237 在 PTEN 缺失的晚期实体瘤患者中的药代动力学特征;
(3) 初步探索生物标记物与抗肿瘤活性的关系。
[Translation] 1. Primary study objectives:
To evaluate the preliminary efficacy of CVL237 tablets in patients with advanced solid tumors with PTEN deletion.
2. Secondary study objectives:
(1) To evaluate the safety of CVL237 in patients with advanced solid tumors with PTEN deletion;
(2) To evaluate the pharmacokinetic characteristics of CVL237 in patients with advanced solid tumors with PTEN deletion;
(3) To preliminarily explore the relationship between biomarkers and anti-tumor activity.