LNK01002 for Myelofibrosis

No longer recruiting at 1 trial location

Overseen By Peter Langecker, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lynk Pharmaceuticals Co., Ltd

Must not be taking: CYP3A inhibitors, inducers

Disqualifiers: Liver disease, HIV, cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new treatment called LNK01002 for people with certain blood cancers, including myelofibrosis, polycythemia vera, and acute myeloid leukemia. Researchers are testing different doses to observe patient responses. This trial may suit those with these conditions, who have symptoms like an enlarged spleen, and who have not found success with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that LNK01002 is likely to be safe for humans?

Research has shown that LNK01002, a multi-kinase inhibitor, is being tested for safety in treating certain blood cancers, including primary myelofibrosis, polycythemia vera, and acute myeloid leukemia. As a phase 1 study, it marks one of the first times the drug is tested in humans, so information about its safety in people remains limited.

These early studies are crucial for observing how people respond to the drug and identifying any side effects. Researchers administer the treatment in varying doses to determine the safest and most effective amount. Since the study is in its early stages, it primarily focuses on checking for negative reactions in participants. This process helps researchers understand how well people tolerate the drug before progressing to larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LNK01002 because it offers a potentially novel approach to treating myeloid conditions like myelofibrosis, polycythemia vera, and acute myeloid leukemia. Unlike traditional treatments that primarily focus on managing symptoms, LNK01002 targets the underlying disease mechanisms, potentially offering a more effective solution. The drug's different dosage levels, ranging from 15 mg to 260 mg, allow for personalized treatment plans based on patient response, which is a significant step forward in tailoring cancer therapies. Additionally, LNK01002's twice-daily dosing and structured observation period could provide insights into its efficacy and safety, potentially leading to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the drug LNK01002, which blocks certain enzymes, may help treat serious blood cancers like myelofibrosis and acute myeloid leukemia. Early results suggest that LNK01002 can affect the processes leading to these cancers. In this trial, participants with malignant myeloid hematologic neoplasms will receive different dosages of LNK01002 to evaluate its effectiveness. For patients with acute myeloid leukemia, studies have found a link between the drug's effects and better survival rates, especially in certain groups. Although the data remains new, LNK01002's targeted action on cancer-related processes offers hope for its effectiveness in these conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

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

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:

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?

Group I: Patients with Primary or Secondary Myelofibrosis,PV Experimental Treatment 1 Intervention

LNK01002 at the RP2D dose in 28-day treatment cycles

Group II: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 FLT3 Experimental Treatment 1 Intervention

LNK01002 at the RP2D dose in 28-day treatment cycles

Group IX: Patients with Acute Myeloid Leukemia With Mutant FLT3 Experimental Treatment 1 Intervention

LNK01002 at the RP2D dose in 28-day treatment cycles

Group X: Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mg Experimental Treatment 1 Intervention

Single dose of LNK01002 15 mg; followed by a 3-day observation period then 15mg BID in 28-day treatment cycles

Who Is Running the Clinical Trial?

Lynk Pharmaceuticals Co., Ltd

Lead Sponsor

Trials

7

Recruited

1,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04896112

NCT04896112 | A Study of LNK01002 in Patients With ... This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39548557/

Outcomes of patients with acute myeloid leukemia and ... The median overall survival (OS) was 14.2 with MF 0-1 versus 7.5 months with MF 2-3 (p < 0.005). In patients aged 60 or older with MF 2-3 median ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568598/

Outcomes of patients with acute myeloid leukemia and ... ... myeloid malignancies [15]. These data suggest that the interrelationship between bone marrow fibrosis and neoplastic hematopoiesis is highly ...

4. moonshotbiobank.cancer.gov moonshotbiobank.cancer.gov/assets/documents/Biomarker-Sample-Report--AML.pdf

Biomarker Sample Report AML Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms. I. NCT03513484. Phase Ib, Open Label, Combination Study of ...

5. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/acute-myelogenous-leukemia

Acute Myelogenous Leukemia Clinical Trials This phase I/IB trial studies the side effects, best dose, and efficacy of azacitidine and erismodegib in treating patients with myeloid malignancies. The ...

6. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/primary-myelofibrosis/

Primary Myelofibrosis Clinical Trials The purpose of this study is to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (MF), or MF due to ...

7. withpower.com withpower.com/trial/phase-1-polycythemia-vera-3-2021-e1eb3

A Study of LNK01002 in Patients With Primary ... Group II: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mgExperimental Treatment1 Intervention. LNK01002 60 mg BID, followed ...

8. moonshotbiobank.cancer.gov moonshotbiobank.cancer.gov/assets/documents/AML-Biomarker-Sample.pdf

AML Biomarker Sample Report ... Safety, Pharmacokinetics and Preliminary. Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms. I. NCT03513484. Phase ...

9. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04896112?keyword=%22Polycythemia%22

San Mateo Clinical Trial A Study of LNK01002 in Patients ... This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms.