[Translation] An open, multicenter, phase I clinical study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of LC004 tablets as a single agent in patients with relapsed/refractory B-lymphocytic malignancies
主要目的:
1、评价 LC004片在复发/难治性B淋巴细胞恶性肿瘤患者中的安全性和耐受性。确定LC004片的最大耐受剂量 (MTD)或最大爬坡剂量 (MAD) ,以及 II 期临床推荐剂量 (RP2D)。
次要目的:
1、描述LC004片不同剂量下口服给药后的药代动力学(PK)特征。
2、描述 LC004片不同剂量下口服给药后的生物标志物(PD)变化。
3、初步评价 LC004片在复发/难治性B淋巴细胞恶性肿瘤患者中的抗肿瘤活性。
4、初步评价 LC004片在 BTK 抑制剂治疗失败(如 BTKC481S基因突变或其他获得性耐药突变)或不耐受患者中的抗肿瘤活性。
[Translation] Primary objectives:
1. Evaluate the safety and tolerability of LC004 tablets in patients with relapsed/refractory B-lymphocyte malignancies. Determine the maximum tolerated dose (MTD) or maximum escalation dose (MAD) of LC004 tablets, as well as the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives:
1. Describe the pharmacokinetic (PK) characteristics of LC004 tablets after oral administration at different doses.
2. Describe the changes in biomarkers (PD) after oral administration of LC004 tablets at different doses.
3. Preliminary evaluation of the anti-tumor activity of LC004 tablets in patients with relapsed/refractory B-lymphocyte malignancies.
4. Preliminary evaluation of the anti-tumor activity of LC004 tablets in patients who have failed BTK inhibitor treatment (such as BTKC481S gene mutations or other acquired resistance mutations) or are intolerant.