A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia

Summary

1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML; 2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects. 3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects; 4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients; 5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.

Timeline

Start

2020-09-15

Primary completion

2024-02

Completion

2024-02

Publications

• Song L, Wei X, Zhai Z, Wang A, Jiang D, Liang Y, Li F, Jiang Z, Zhang X, Guo Q, Jing H, Xu Y, Tong X, Wang J, Wang J, Qi J. Phase I/II Trial of the FLT3 Kinase Inhibitor XY0206 in Patients With Relapsed/Refractory Acute Myeloid Leukemia. Eur J Haematol. 2026 Apr 21. doi: 10.1111/ejh.70164. Online ahead of print.

Drugs

Indications