Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML) (NCT06530810) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)
100 participantsStarted 2024-07-31
Plain-language 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. Flumatinib is the first approved second generation TKI in China and a derivative of imatinib.
The primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia (CML).
The secondary objectives is to evaluate the PK profile, major metabolites and efficacy of HS-10382 in CML-CP/AP subjects after combination therapy, and to explore the kinase domain mutations associated with TKI resistance
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* ECOG performance status of 0-1 and no worsening within 2 weeks before the first dose.
* Life expectancy ≥ 12 weeks.
* 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.
* Females must have evidence of non-childbearing potential.
Exclusion Criteria:
* 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.
* Previous treatment with a BCR-ABL1 TKI allosteric inhibitor .
* Impaired cardiac function including any one of the following:
* 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).
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,
* Left ventricular ej…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) for HS-10382 combined treatment