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Chronic Myelogenous LeukemiaPhase 1NCT06530810

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

A Phase 1 study testing HS-10382+Flumatinib in people with Chronic Myelogenous Leukemia and CML Chronic Phase, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HS-10382+Flumatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
31 Jul 2024to 8 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 22Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yu Hu, PhD contact

13986183871

dr_huyu@126.com

About this study

Official title: A Phase 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10382 Combination Therapy in Patients With Chronic Myeloid Leukemia

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

Being tested
HS-10382+Flumatinib
Keywords
CML-CP/AP, HS-10382, Flumatinib, Allosteric inhibitor
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10382+FlumatinibDrug

    Drug:HS-10382+Flumatinib HS-10382 is administered orally BID Drug:Flumatinib Flumatinib 400mg once daily

Study groups in NCT06530810
Study groupRoleWhat they receive
HS-10382+FlumatinibExperimentalSubjects with resistant or intolerant CML CP/AP will be enrolled in dose-escalation stage.Dose escalation of HS-10382 combined flumatinib will be done to determine maximum tolerated dose(Part 1). Depending on data obtained from the dose-escalation stage,dose expansion may proceed with in subjects with newly diagnosed CML-CP.The safety and efficacy will be evaluated at the target dose.(Part 2)
Receives: Drug: HS-10382+Flumatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) for HS-10382 combined treatment

    MTD was defined as the previous dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT

    Measured: Up to day 28 from the first dose

Secondary outcomes (11)

  1. Incidence and severity of treatment-emergent adverse events

    Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0

    Measured: Cycle 1 day 1 up to 28 days after the last dose

  2. maximum plasma concentration of HS-10382 or Flumatinib(and its major metabolite ) after HS-10382 combination therapy

    Cmax is the maximum observed concentration.

    Measured: Cycle 1 day 1 up to 28 days after the last dose

  3. Time to reach maximum plasma concentration of HS-10382 or Flumatinib(and its major metabolite) after HS-10382 combination therapy

    Tmax is defined as time to reach maximum observed plasma concentration

    Measured: Cycle 1 day 1 up to 28 days after the last dose

  4. half-life (T1/2) of HS-10382 combination therapy

    half-life is the time measured for the concentration to decrease by one half

    Measured: Cycle 1 day 1 up to 28 days after the last dose

  5. Area under the curve (AUC) of HS-10382 combination therapy

    The AUC is defined as the area under the plasma concentration-time curve

    Measured: Cycle 1 day 1 up to 28 days after the last dose

  6. Hematologic Response of combination therapy with HS-10382

    To record and analyse the hematologic response of subjects. Hematologic response will be assessed by complete blood count (CBC) and physical examination at each visit.

    Measured: up to 24 months

  7. Cytogenetic Response of combination therapy with HS-10382

    To record and analyse the cytogenetic response of subjects. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample.

    Measured: up to 24 months

  8. Molecular Response of combination therapy with HS-10382

    To record and analyse the molecular response of subjects. Molecular response will be assessed by BCR-ABL1 transcript level as measured by RQ-PCR.

    Measured: up to 24 months

  9. Event-free survival (EFS)

    EFS is defined as the time from the date of first dose to the earliest occurrence of the following events: death due to any cause ; loss of CHR ,loss of PCyR ;loss of CCyR ; discontinuation of study treatment due to AE or treatment failure ; progression to AP/BC .

    Measured: up to 24 months

  10. Progression-free survival (PFS)

    PFS is defined as the time from the date of first dose to the earliest occurrence of progression to AP/BC or death from any cause.

    Measured: From the first dose to disease progression or withdrawal from study, whichever came first,up to 24 months

  11. Overall survival (OS)

    OS is defined as the time from the date of first dose to the date of death from any cause.

    Measured: From the first dose up to death or withdrawal from study, whichever came first, up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start31 Jul 2024 (estimated)
  3. Primary completion8 May 2026 (estimated)
  4. Study completion8 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06530810
Sponsor's protocol ID
HS-10382-102
Status last verified
Jul 2024
First submitted
19 Jul 2024
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10382+Flumatinib in people with Chronic Myelogenous Leukemia and CML Chronic Phase, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yu Hu, PhD (13986183871, dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) for HS-10382 combined treatment (time frame: Up to day 28 from the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06530810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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