A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
Signed informed consent form.
Men or women aged more than or equal to (≥) 18 years, and less than (<) 75 years.
CML-CP/AP patients with the Ph chromosome or BCR-ABL1 fusion genes.
Patient with CML-CP/AP who are resistant to or intolerant to previous TKIs therapy.
Disqualifiers
CML-CP patients who have acquired CCyR and have not lost it.
Patients with CML-CP who have progressed to AP or blast phase(BP.)
Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood.
Patients with CML-AP who have progressed to BP.
Trial design
Treatments tested in this trial
- HS-10382(Part 1: Dose escalation)
- HS-10382(Part 2: Dose expansion)
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov