RecruitingPhase 1NCT05367700

A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.

A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10382 in Patients With Chronic Myeloid Leukemia.


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

108 participants

Start Date

Apr 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HS-10382 for people with chronic myeloid leukemia (CML) — a blood cancer — whose disease is not responding to or cannot tolerate existing targeted therapies called TKIs. HS-10382 works differently from current TKIs and may help patients resistant to them. **You may be eligible if...** - You are 18–74 years old - You have chronic myeloid leukemia in the chronic or accelerated phase - Your CML has a gene change called BCR-ABL1 or the Philadelphia chromosome - Your disease is resistant to or you cannot tolerate current TKI medications - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if...** - Your CML is currently well controlled on TKI therapy - Your CML has progressed to blast phase - You have had prior treatment with a BCR-ABL1 allosteric inhibitor - You have serious heart rhythm problems or low heart pumping function - You have had a heart attack or heart failure in the last 6 months - You have a history of pancreatitis - You have severe, uncontrolled high blood pressure or diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-10382(Part 1: Dose escalation)

Single or multiple dose(s) of HS-10382 once daily.

DRUGHS-10382(Part 2: Dose expansion)

HS-10382 is administered orally once daily.


Locations(1)

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT05367700


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