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New treatment option for CML, Chronic Phase
Official title A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
ClinicalTrials.gov ID: NCT05367700
What this study is testing
What is HS-10382(Part 1: Dose escalation)?
HS-10382(Part 1: Dose escalation) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cml, chronic phase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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 0-2.
You likely can't join if
- 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:
See the full eligibility 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 0-2.
- 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.
- 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 ejection fraction (LVEF) ≤ 50%.
- During screening period, ECG examination showed average heart rate \<50 beats per minute.
- Myocardial infarction occurred within 6 months of the first scheduled dose of HS-10382.;
- Congestive heart failure occurred within 6 months of the first scheduled dose of HS-10382.;
- Uncontrollable angina.
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
- Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).
- Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.
- Severe infection within 4 weeks prior to the first scheduled dose of HS-10382.
- History of significant congenital or acquired bleeding disorders unrelated to CML.
- Inadequate other organ function.
- History of other malignancies.
- History of hypersensitivity to any active or inactive ingredient of HS-10382.
- History of neuropathy or mental disorders, including epilepsy and dementia.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.