Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HS-10382 for patients with chronic myeloid leukemia (CML), which is a type of blood cancer. HS-10382 works by blocking a specific protein that helps the cancer grow, potentially making it easier to manage the disease. The trial aims to find out how safe this treatment is when combined with another medication called flumatinib, and whether it works well for patients who have not responded to previous therapies.

To participate in this study, patients need to be adults aged 18 to 74 who have been diagnosed with CML and have certain genetic markers. They should also have already tried other treatments without success. Participants will need to provide consent and will be monitored closely during the trial. It's important to note that this trial is not yet recruiting participants, so individuals interested in joining will need to wait until it begins. Overall, this study is an opportunity for eligible patients to explore a potentially new treatment option for their condition.

Gender

ALL

Eligibility criteria

• 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 ejection fraction (LVEF) ≤ 50%.
• • Myocardial infarction occurred within 6 months of the first scheduled dose of study drug.;
• • Congestive heart failure occurred within 6 months of the first scheduled dose of study drug.;
• • 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 study drug
• • Inadequate other organ function.
• • History of other malignancies.
• • History of hypersensitivity to any active or inactive ingredient of HS-10382 and flumatinib.
• • 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