[Translation] Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of DG01 in patients with prostate cancer
主要研究目的:
1、评估DG01的安全性、耐受性和最大耐受剂量(MTD)及临床II期推荐剂量(RP2D);
2、评估DG01在前列腺癌患者中的药代动力学特征。
次要研究目的:
1、评估DG01在前列腺癌患者中的初步有效性。
探索性目的:
1、探索DG01在前列腺癌患者中抗肿瘤疗效相关生物标志物的表达。
[Translation] Main research objectives:
1. Evaluate the safety, tolerability and maximum tolerated dose (MTD) of DG01 and the recommended dose (RP2D) for phase II clinical trials;
2. Evaluate the pharmacokinetic characteristics of DG01 in patients with prostate cancer.
Secondary research objectives:
1. Evaluate the preliminary efficacy of DG01 in patients with prostate cancer.
Exploratory objectives:
1. Explore the expression of biomarkers related to the anti-tumor efficacy of DG01 in patients with prostate cancer.