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

Recruiting at 1 trial location
SW
PL
Overseen ByPeter Langecker, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Lynk Pharmaceuticals Co., Ltd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received certain cancer treatments, radiotherapy, or specific herbal medicines shortly before starting the study. It's best to discuss your current medications with the trial team.

How does the drug LNK01002 work differently from other treatments?

LNK01002 may involve targeting the dual leucine zipper kinase (DLK), which plays a role in neuronal responses to injury and disease, potentially offering a novel approach by influencing pathways involved in neuron protection and regeneration.12345

What data supports the effectiveness of the drug LNK01002?

The research suggests that LNK, a component related to LNK01002, plays a role in melanoma by regulating cell growth and survival, and its manipulation could enhance the effectiveness of interferon treatment. This indicates potential therapeutic benefits of targeting LNK in cancer treatment.678910

Who Is on the Research Team?

LW

Linda Wei, M.D.

Principal Investigator

Lynk Pharmaceuticals Co., Ltd

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a type of blood cancer called PMF, PV/ET-MF, or AML and have either relapsed or are unable to tolerate standard treatment.
Platelet count ≥ 100 × 10e9/L within 14 days before study drug administration
Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L within 14 days before study drug administration
See 6 more

Exclusion Criteria

Received CYP3A substrates, CYP2B6 substrates, CYP2C substrates, OATP1B3 substrates, UGT1A1 inhibitors, or UGT1A3 inhibitors less than one week or 5 half-lives (whichever is longer) prior to the start of study treatment;
Uncontrolled, active infections requiring intravenous antibiotic treatment;
Known history of clinically significant liver disease, including viral or other hepatitis:
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Successive cohorts of patients are enrolled to establish the maximum tolerated dose of LNK01002

31 days
Multiple visits for dose adjustments and monitoring

Dose Expansion

Patients are enrolled in cohorts to confirm the dose and evaluate safety, tolerability, and preliminary efficacy

24 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LNK01002
How Is the Trial Designed?
10Treatment groups
Experimental Treatment
Group I: Patients with Primary or Secondary Myelofibrosis,PVExperimental Treatment1 Intervention
Group II: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mgExperimental Treatment1 Intervention
Group III: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mgExperimental Treatment1 Intervention
Group IV: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mgExperimental Treatment1 Intervention
Group V: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mgExperimental Treatment1 Intervention
Group VI: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mgExperimental Treatment1 Intervention
Group VII: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mgExperimental Treatment1 Intervention
Group VIII: Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3Experimental Treatment1 Intervention
Group IX: Patients with Acute Myeloid Leukemia With Mutant FLT3Experimental Treatment1 Intervention
Group X: Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lynk Pharmaceuticals Co., Ltd

Lead Sponsor

Trials
7
Recruited
1,300+

Citations

LNK suppresses interferon signaling in melanoma. [2021]
Phosphorylation of p53 by LRRK2 induces microglial tumor necrosis factor α-mediated neurotoxicity. [2018]
Small molecule kinase inhibitor LRRK2-IN-1 demonstrates potent activity against colorectal and pancreatic cancer through inhibition of doublecortin-like kinase 1. [2022]
Leucine-Rich Repeat Kinase 2 (LRRK2) Stimulates IL-1β-Mediated Inflammatory Signaling through Phosphorylation of RCAN1. [2020]
The Parkinson disease-associated protein kinase LRRK2 exhibits MAPKKK activity and phosphorylates MKK3/6 and MKK4/7, in vitro. [2022]
Multitasking: Dual Leucine Zipper-Bearing Kinases in Neuronal Development and Stress Management. [2020]
The DLK-1 kinase promotes mRNA stability and local translation in C. elegans synapses and axon regeneration. [2022]
DLK silencing attenuated neuron apoptosis through JIP3/MA2K7/JNK pathway in early brain injury after SAH in rats. [2018]
The c-Jun N-terminal kinase activator dual leucine zipper kinase regulates axon growth and neuronal migration in the developing cerebral cortex. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Identification and characterization of neuronal mitogen-activated protein kinase substrates using a specific phosphomotif antibody. [2022]
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