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Multi-Kinase Inhibitor

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

Phase 1
Waitlist Available
Research Sponsored by Lynk Pharmaceuticals Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, and day 15
Awards & highlights
No Placebo-Only Group

Summary

This trial tests LNK01002, a drug that blocks proteins needed for cancer cell growth, in patients with certain blood cancers. It aims to find the safest dose and see how well the drug works.

Eligible Conditions
  • Myelofibrosis
  • Polycythemia Vera
  • Primary Myelofibrosis
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, and day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, and day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessing maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Assessing the preliminary antitumor activity of LNK01002
Assessing the safety and tolerability of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Secondary study objectives
Measurement of pharmacokinetic (PK) parameter, AUC, in MF, PV,PV-MF or ET-MF patients
Measurement of pharmacokinetic (PK) parameter, CL/F, in MF, PV, PV-MF or ET-MF patients
Measurement of pharmacokinetic (PK) parameter, Cmax, in MF, PV,PV-MF or ET-MF patients
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups
Experimental Treatment
Group I: Patients with Primary or Secondary Myelofibrosis,PVExperimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group II: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mgExperimental Treatment1 Intervention
LNK01002 60 mg BID, followed by a 3-day observation period then 60 mg BID in 28-day treatment cycles
Group III: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mgExperimental Treatment1 Intervention
LNK01002 30 mg twice daily (BID), followed by a 3-day observation period then 30 mg BID in 28-day treatment cycles
Group IV: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mgExperimental Treatment1 Intervention
LNK01002 260 mg BID, followed by a 3-day observation period then 260 mg BID in 28-day treatment cycles
Group V: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mgExperimental Treatment1 Intervention
LNK01002 200 mg BID, followed by a 3-day observation period then 200 mg BID in 28-day treatment cycles
Group VI: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mgExperimental Treatment1 Intervention
LNK01002 150 mg BID, followed by a 3-day observation period then 150 mg BID in 28-day treatment cycles
Group VII: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mgExperimental Treatment1 Intervention
LNK01002 100 mg BID, followed by a 3-day observation period then 100 mg BID in 28-day treatment cycles
Group VIII: Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3Experimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group IX: Patients with Acute Myeloid Leukemia With Mutant FLT3Experimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group X: Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mgExperimental Treatment1 Intervention
Single dose of LNK01002 15 mg; followed by a 3-day observation period then 15mg BID in 28-day treatment cycles

Find a Location

Who is running the clinical trial?

Lynk Pharmaceuticals Co., LtdLead Sponsor
6 Previous Clinical Trials
1,295 Total Patients Enrolled
Sherry Weigand, M.D., Ph.D.Study DirectorLynk Pharmaceuticals Co., Ltd
Linda Wei, M.D.Study DirectorLynk Pharmaceuticals Co., Ltd
~0 spots leftby Dec 2025
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