Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HS-10382+Flumatinib
DrugDrug:HS-10382+Flumatinib HS-10382 is administered orally BID Drug:Flumatinib Flumatinib 400mg once daily
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: HS-10382+FlumatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Up to day 28 from the first doseSecondary outcomes
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
Time frame
Cycle 1 day 1 up to 28 days after the last dose2
maximum plasma concentration of HS-10382 or Flumatinib(and its major metabolite ) after HS-10382 combination therapy
Cmax is the maximum observed concentration.
Time frame
Cycle 1 day 1 up to 28 days after the last dose3
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
Time frame
Cycle 1 day 1 up to 28 days after the last dose4
half-life (T1/2) of HS-10382 combination therapy
half-life is the time measured for the concentration to decrease by one half
Time frame
Cycle 1 day 1 up to 28 days after the last doseLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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