[Translation] An open, multicenter, phase I clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of HE006 tablets as a single-drug treatment for patients with relapsed/refractory acute myeloid leukemia
主要目的
1.评价HE006片在复发/难治性急性髓系白血病患者中的安全性和耐受性;
2.确定HE006片的最大耐受剂量(MTD)或最大爬坡剂量(MAD),以及II期推荐剂量(RP2D)。
次要目的
1.评价HE006片在复发/难治性急性髓系白血病患者中单次、多次口服给药后的药代动力学(PK)特征;
2.评价HE006片在复发/难治性急性髓系白血病患者中的临床有效性。
其他目的
1.评价HE006片在复发/难治性急性髓系白血病患者中药效动力学(PD)指标的变化;
2.评价HE006片在复发/难治性急性髓系白血病患者中的暴露与疗效和不良事件(AE)之间的关系(如数据允许的情况下);
3.鉴定HE006片在复发/难治性急性髓系白血病患者中血浆代谢产物(如适用)。
[Translation] Main objectives
1. To evaluate the safety and tolerability of HE006 tablets in patients with relapsed/refractory acute myeloid leukemia;
2. To determine the maximum tolerated dose (MTD) or maximum escalation dose (MAD) of HE006 tablets, as well as the recommended dose for phase II (RP2D).
Secondary objectives
1. To evaluate the pharmacokinetic (PK) characteristics of HE006 tablets after single and multiple oral administration in patients with relapsed/refractory acute myeloid leukemia;
2. To evaluate the clinical effectiveness of HE006 tablets in patients with relapsed/refractory acute myeloid leukemia.
Other objectives
1. To evaluate the changes in pharmacodynamic (PD) indicators of HE006 tablets in patients with relapsed/refractory acute myeloid leukemia;
2. To evaluate the relationship between exposure, efficacy and adverse events (AEs) of HE006 tablets in patients with relapsed/refractory acute myeloid leukemia (if data permit);
3. To identify plasma metabolites of HE006 tablets in patients with relapsed/refractory acute myeloid leukemia (if applicable).