[Translation] A dose-escalation, dose-expansion, open-label, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss-of-function mutations and/or other defects in the DNA damage repair (DDR) pathway
本研究主要目的为评估PARG抑制剂DAT-2645在携带BRCA1/2功能缺失突变和/或DDR通路中其他缺陷的晚期或转移性实体瘤中的安全性、耐受性、PK、PD指标及初步临床疗效,确定MTD和RP2D,为后续开展临床试验提供I期临床试验数据。
[Translation] The main purpose of this study is to evaluate the safety, tolerability, PK, PD indicators and preliminary clinical efficacy of the PARG inhibitor DAT-2645 in advanced or metastatic solid tumors carrying BRCA1/2 loss-of-function mutations and/or other defects in the DDR pathway, determine the MTD and RP2D, and provide Phase I clinical trial data for subsequent clinical trials.