A Study of LNK01002 in Patients With Primary or Secondary Myelofibrosis,Polycythemia Vera or Acute Myeloid Leukemia

Last updated: June 15, 2023
Sponsor: Lynk Pharmaceuticals Co., Ltd
Overall Status: Trial Not Available

Phase

1

Condition

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Thrombosis

Treatment

LNK01002

Clinical Study ID

NCT04896112
LNK-1002-01
IND 153144
  • Ages 18-99
  • All Genders

Study Summary

This multicenter, open-label, phase 1 study designed to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (PMF), or MF due to polycythemia vera (PV-MF), or essential thrombocythemia (ET-MF), polycythemia vera (PV), or with acute myeloid leukemia (AML).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 18 years old or older, male or female.
  2. Patients must have histologically or cytologically confirmed tumors of the followingtypes.
  • Dose Escalation Phase: Patients with PMF,PV/ET-MF,PV
  1. Intermediate or high-risk primary myelofibrosis, intermediate or high-riskpost-polycythemia vera myelofibrosis , or post-essential thrombocythemiamyelofibrosis , or high-risk polycythemia vera who have no available therapyor relapsed after allogeneic hematopoietic cell transplantation.
  2. Symptomatic splenomegaly
  3. Not undergone splenectomy or splenic radiation therapy within 6 months priorto screening.
  • Dose expansion phase: Patients with PMF, PV/ET-MF,PV who relapsed or areintolerant to standard treatment, and relapsed/refractory AML
  1. Platelet count ≥ 100 × 10e9/L within 14 days before study drug administration
  2. Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L within 14 days before study drugadministration
  3. Women of childbearing potential negative pregnancy test at screening. Female patientsof childbearing potential, or male patients and their partners should agree toeffective contraception from signing ICF until 6 months after the last dose of studydrug.

Exclusion

Exclusion Criteria: Patients who meet any of the following exclusion criteria will be excluded from theclinical study:

  1. Allergic to any component of LNK01002.
  2. Serum total bilirubin greater than 1.5 times the upper limit of the normal (ULN)reference range, except patients diagnosed as Gilbert's disease
  3. ALT or AST higher than 3 times the ULN reference range without hepatic involvement byleukemia, which are excluded if higher than 5 times the ULN
  4. Glomerular filtration rate or estimated creatinine clearance < 50 mL/min according tothe Cockcroft-Gault formula;
  5. Serum amylase or lipase levels higher than the ULN and considered clinicallysignificant
  6. International normalized ratio (INR) or partial activated prothrombin time (aPTT)above 1.5 times the ULN reference range
  7. Known history of clinically significant liver disease, including viral or otherhepatitis: a) Patients with hepatitis B or hepatitis C may be enrolled if they have a negativepolymerase chain reaction (PCR)
  8. Known human immunodeficiency virus (HIV) infection;
  9. Clinically significant cardiovascular diseases, including acute myocardial infarction,unstable angina, coronary artery bypass surgery within 6 months before enrollment,congestive heart failure with New York Heart Association (NYHA) classification of IIIor above, left ventricular ejection fraction (LVEF) < 50%, or uncontrolledhypertension, cardiac arrhythmia;
  10. Patients with history or presence of clinically relevant non-malignant CNS diseaserequiring treatment;
  11. Patients who have received systemic antineoplastic therapy or radiotherapy within 2weeks prior to start of study treatment;
  12. Patients who have received hematopoietic stem cell transplantation (HSCT) within 60days prior to the start of study treatment, or are receiving immunosuppressive therapyafter HSCT at screening, or have graft-versus-host disease (GVHD) requiring ongoingtreatment;
  13. Received anti-tumor Chinese herbal medicine treatment within 1 week before the startof study treatment;
  14. Received CYP3A strong inhibitors or strong inducers less than one week or 5 half-lives (whichever is longer) prior to the start of study treatment;
  15. Uncontrolled, active infections requiring intravenous antibiotic treatment;

Study Design

Treatment Group(s): 1
Primary Treatment: LNK01002
Phase: 1
Study Start date:
April 08, 2021
Estimated Completion Date:
October 20, 2022

Study Description

This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms. The study consists of two periods: the dose escalation, main period and a dose expansion period. In the dose escalation period, successive cohorts of patients with Malignant Myeloid Hematologic Neoplasms will be enrolled to establish the maximum tolerated dose. In the dose expansion period (dose-confirmation phase), three cohorts of patients will be enrolled: AML patients with confirmed FLT3-ITD mutations, AML patients without FLT3-ITD mutations, and patients with primary MF ,PV or PV/ET-MF.

The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms will be evaluated.

Connect with a study center

  • Revive Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Revive Research Institute, Inc.

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Revive Research Institute

    Sterling Heights, Michigan 48314
    United States

    Site Not Available

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