Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

Summary

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.

Timeline

Start

2020-01-09

Primary completion

2029-12-27

Completion

2030-03-31

Publications

• Jabbour E, Oehler VG, Koller PB, Jamy O, Lomaia E, Hunter AM, Uspenskaya O, Samarina S, Mukherjee S, Cortes JE, Baer MR, Zherebtsova V, Shuvaev V, Turkina A, Davydkin I, Guo H, Chen Z, Fu T, Jiang L, Wang C, Wang H, Yang D, Zhai Y, Kantarjian H. Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib: A Phase 1b Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):28-35. doi: 10.1001/jamaoncol.2024.5157.
• Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z.

Drugs

Indications