A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ETH-155008 Tablets in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Non-Hodgkin's Lymphoma
This Trial is an open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with AML and NHL who previously received standard treatment or are ineligible for standard treatment options.
ETH-155008 片在复发性或难治性急性髓系白血病和非霍奇金淋巴瘤患者中的安全性、耐受性 、药代动力学和初步疗效的 I 期临床研究
主要目的:
1. 评价 ETH-155008在复发性或难治性急性髓系白血病(AML)和非霍奇金淋巴瘤(NHL)患者的安全性和耐受性,
2. 确定ETH-155008的最大耐受剂量(MTD),以及II期推荐剂量(RP2D)。
次要目的:
1. 评价 ETH-155008 在复发性或难治性AML和NHL患者中单次、多次口服给药后的药代动力学(PK)特征;
2. 评价 ETH-155008 的药效动力学(PD)特征;
3. 评价 ETH-155008 在复发性或难治性AML和NHL患者中的初步抗肿瘤疗效。
4. 评价对ETH-155008治疗反应的生物标志物,可能包括但不限于与有效/耐药相关的基因突变和表达特征。
A Phase 1a/1b Dose Escalation and Dose Expansion, First-in-human, Open-Labeled Study of ETH-155008 in Subjects With Relapsed or Refractory B-cell NHL, CLL/SLL and AML
This Trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with R/R B-cell NHL, CLL/SLL and AML who previously received standard treatment or are ineligible for standard treatment options.
100 项与 ETH-155008 相关的临床结果
100 项与 ETH-155008 相关的转化医学
100 项与 ETH-155008 相关的专利(医药)
100 项与 ETH-155008 相关的药物交易