NCT05367700 A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
| NCT ID | NCT05367700 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Condition | CML, Chronic Phase |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 108 participants in total. It began in 2022-04-28 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Impaired cardiac function including any one of the following: 1. Resting corrected QT interval (QTc) \> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF). 2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG. 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, 4. Left ventricular ejection fraction (LVEF) ≤ 50%. 5. During screening period, ECG examination showed average heart rate \<50 beats per minute. 6. Myocardial infarction occurred within 6 months of the first scheduled dose of HS-10382.; 7. Congestive heart failure occurred within 6 months of the first scheduled dose of HS-10382.; 8. Uncontrollable angina. 7. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis 8. Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes). 9. Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption. 10. Severe infection within 4 weeks prior to the first scheduled dose of HS-10382. 11. History of significant congenital or acquired bleeding disorders unrelated to CML. 12. Inadequate other organ function. 13. History of other malignancies. 14. History of hypersensitivity to any active or inactive ingredient of HS-10382. 15. History of neuropathy or mental disorders, including epilepsy and dementia. 16. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Contact & Investigator
Yu Hu
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT05367700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying CML, Chronic Phase. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05367700 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05367700 currently recruiting?
Yes, NCT05367700 is actively recruiting participants. Contact the research team at dr_huyu@126.com for enrollment information.
Where is the NCT05367700 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05367700 clinical trial?
NCT05367700 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. The principal investigator is Yu Hu at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 108 participants.