[Translation] A Phase I open-label study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of DC50292A tablets in patients with advanced or metastatic solid tumors with MTAP deletion
主要目的
评估DC50292A片在MTAP缺失的晚期或转移性实体瘤患者中的安全性和耐受性,确定剂量限制性毒性(DLT)、最大耐受剂量(MTD)及Ⅱ期临床试验推荐剂量(RP2D)。
次要目的
评估DC50292A片在MTAP缺失的晚期或转移性实体瘤患者中的药代动力学(PK)特征;
初步评估DC50292A片在MTAP缺失的晚期或转移性实体瘤患者中的抗肿瘤疗效。
探索性目的
通过校正QTc间期探索血清/肿瘤组织中SDMA水平较基线变化及其与DC50292A片剂量、血浆暴露量、抗肿瘤活性的相关性;
探索血浆中ctDNA较基线变化及其与DC50292A片剂量、血浆暴露量、抗肿瘤活性的相关性。
及PK(PK /QTc)评估心脏安全性。
[Translation] Primary objective
To evaluate the safety and tolerability of DC50292A tablets in patients with advanced or metastatic solid tumors with MTAP deletion, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RP2D) for phase II clinical trials.
Secondary objective
To evaluate the pharmacokinetic (PK) characteristics of DC50292A tablets in patients with advanced or metastatic solid tumors with MTAP deletion;
To preliminarily evaluate the anti-tumor efficacy of DC50292A tablets in patients with advanced or metastatic solid tumors with MTAP deletion.
Exploratory objective
To explore the changes in SDMA levels in serum/tumor tissues from baseline and their correlation with the dose, plasma exposure, and anti-tumor activity of DC50292A tablets by correcting the QTc interval;
To explore the changes in ctDNA in plasma from baseline and their correlation with the dose, plasma exposure, and anti-tumor activity of DC50292A tablets.
And PK (PK/QTc) to evaluate cardiac safety.