A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Trial Parameters
Brief Summary
HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic(PK) profile of HS-10382 in patients with chronic myeloid leukemia (CML). Anti-CML activity will also be investigated in this study.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form. 2. Men or women aged more than or equal to (≥) 18 years, and less than (\<) 75 years. 3. CML-CP/AP patients with the Ph chromosome or BCR-ABL1 fusion genes. 4. Patient with CML-CP/AP who are resistant to or intolerant to previous TKIs therapy. 5. ECOG performance status of 0-2. 6. Life expectancy ≥ 12 weeks. 7. Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study. 8. Females must have evidence of non-childbearing potential. Exclusion Criteria: 1. CML-CP patients who have acquired CCyR and have not lost it. 2. Patients with CML-CP who have progressed to AP or blast phase(BP.) 3. Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood. 4. Patients with CML-AP who have progressed to BP. 5. Previous treatment with a BCR-ABL1 TKI allosteric inhibitor . 6.