Acute Myeloid LeukemiaPhase 1NCT04896112

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

A Phase 1 study testing LNK01002 in people with Acute Myeloid Leukemia and Primary Myelofibrosis, run by Lynk Pharmaceuticals Co., Ltd at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Acute Myeloid Leukemia, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
What is being tested?: LNK01002
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 2 sitesUnited States
Study dates: 8 Apr 2021to 20 Oct 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18 years old or older, male or female.
Patients must have histologically or cytologically confirmed tumors of the following types.
Dose Escalation Phase: Patients with PMF,PV/ET-MF,PV
Intermediate or high-risk primary myelofibrosis, intermediate or high-risk post-polycythemia vera myelofibrosis , or post-essential thrombocythemia myelofibrosis , or high-risk polycythemia vera who have no available therapy or relapsed after allogeneic hematopoietic cell transplantation.
Symptomatic splenomegaly
Not undergone splenectomy or splenic radiation therapy within 6 months prior to screening.

Show all 10Show fewer

Dose expansion phase: Patients with PMF, PV/ET-MF,PV who relapsed or are intolerant to standard treatment, and relapsed/refractory AML
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
Women of childbearing potential negative pregnancy test at screening. Female patients of childbearing potential, or male patients and their partners should agree to effective contraception from signing ICF until 6 months after the last dose of study drug.

Who cannot join

Patients who meet any of the following exclusion criteria will be excluded from the clinical study:
Allergic to any component of LNK01002.
Serum total bilirubin greater than 1.5 times the upper limit of the normal (ULN) reference range, except patients diagnosed as Gilbert's disease
ALT or AST higher than 3 times the ULN reference range without hepatic involvement by leukemia, which are excluded if higher than 5 times the ULN
Glomerular filtration rate or estimated creatinine clearance < 50 mL/min according to the Cockcroft-Gault formula;
Serum amylase or lipase levels higher than the ULN and considered clinically significant

Show all 17Show fewer

International normalized ratio (INR) or partial activated prothrombin time (aPTT) above 1.5 times the ULN reference range
Known history of clinically significant liver disease, including viral or other hepatitis:
Patients with hepatitis B or hepatitis C may be enrolled if they have a negative polymerase chain reaction (PCR)
Known human immunodeficiency virus (HIV) infection;
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 III or above, left ventricular ejection fraction (LVEF) < 50%, or uncontrolled hypertension, cardiac arrhythmia;
Patients with history or presence of clinically relevant non-malignant CNS disease requiring treatment;
Patients who have received systemic antineoplastic therapy or radiotherapy within 2 weeks prior to start of study treatment;
Patients who have received hematopoietic stem cell transplantation (HSCT) within 60 days prior to the start of study treatment, or are receiving immunosuppressive therapy after HSCT at screening, or have graft-versus-host disease (GVHD) requiring ongoing treatment;
Received anti-tumor Chinese herbal medicine treatment within 1 week before the start of study treatment;
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;
Uncontrolled, active infections requiring intravenous antibiotic treatment;

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Revive Research Institute
Farmington Hills, Michigan, 48334
Revive Research Institute
Sterling Heights, Michigan, 48314

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms

Read the detailed 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.

Conditions: Acute Myeloid Leukemia, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera
Being tested: LNK01002
Keywords: Malignant Myeloid Hematologic Neoplasms, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Myeloid malignancies, Myelofibrosis, Polycythemia Vera, Acute Myeloid Leukemia
Medical subject headings: Leukemia, Myeloid, Acute, Primary Myelofibrosis, Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LNK01002Drug
Also called LNK-1000318
LNK01002 will be administrated orally.

Study groups in NCT04896112
Study group	Role	What they receive
Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mg	Experimental	Single dose of LNK01002 15 mg; followed by a 3-day observation period then 15mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mg	Experimental	LNK01002 30 mg twice daily (BID), followed by a 3-day observation period then 30 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mg	Experimental	LNK01002 60 mg BID, followed by a 3-day observation period then 60 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mg	Experimental	LNK01002 100 mg BID, followed by a 3-day observation period then 100 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mg	Experimental	LNK01002 150 mg BID, followed by a 3-day observation period then 150 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mg	Experimental	LNK01002 200 mg BID, followed by a 3-day observation period then 200 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mg	Experimental	LNK01002 260 mg BID, followed by a 3-day observation period then 260 mg BID in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Acute Myeloid Leukemia With Mutant FLT3	Experimental	LNK01002 at the RP2D dose in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3	Experimental	LNK01002 at the RP2D dose in 28-day treatment cycles Receives: Drug: LNK01002
Patients with Primary or Secondary Myelofibrosis,PV	Experimental	LNK01002 at the RP2D dose in 28-day treatment cycles Receives: Drug: LNK01002

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessing the safety and tolerability of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Assessed by monitoring the frequency, duration and severity of adverse events and serious adverse events.
Measured: 31 days
Assessing maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be assessed based on the safety profile by the SRC
Measured: 31 days
Assessing the preliminary antitumor activity of LNK01002
The preliminary antitumor activity will be analyzed in patients with different types of malignant myeloid hematologic neoplasms by response rate using bone marrow and hematologic analyses (MF/AML) or by the MF Symptom Assessment Scale and spleen volume by MRI (MF).
Measured: 24 Weeks

Secondary outcomes (7)

Measurement of pharmacokinetic (PK) parameter, AUC, in MF, PV,PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Cmax, in MF, PV,PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Tmax, in MF, PV, PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, CL/F, in MF, PV, PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, T1/2, in MF, PV, PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Vz/F, in MF, PV,PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, MRT, in MF, PV,PV-MF or ET-MF patients
Measurement will be using extensive PK sampling
Measured: Day 1, Day 2, and Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202120 Oct 2022

First posted21 May 2021
Study start8 Apr 2021
Primary completion20 Oct 2022
Study completion20 Oct 2022

Why it stopped: sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04896112
Sponsor's protocol ID: LNK-1002-01
Other IDs: IND 153144
Status last verified: Jun 2023
First submitted: 8 May 2021
Last updated: 18 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms
ClinicalTrials.gov ID: NCT04896112
Acronym / sponsor ID: LNK-1002-01
Conditions: Acute Myeloid Leukemia, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera
Keywords: Malignant Myeloid Hematologic Neoplasms, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Myeloid malignancies, Myelofibrosis, Polycythemia Vera, Acute Myeloid Leukemia
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: sponsor decision
Enrolment: 0 participants (actual)
Lead sponsor: Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
Study start: 8 Apr 2021 (actual)
Primary completion: 20 Oct 2022 (actual)
Study completion: 20 Oct 2022 (actual)
First posted: 21 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 10
Model description: An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002

Arm	Type	Receives
Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mg	Experimental	Drug: LNK01002Single dose of LNK01002 15 mg; followed by a 3-day observation period then 15mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mg	Experimental	Drug: LNK01002LNK01002 30 mg twice daily (BID), followed by a 3-day observation period then 30 mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mg	Experimental	Drug: LNK01002LNK01002 60 mg BID, followed by a 3-day observation period then 60 mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mg	Experimental	Drug: LNK01002LNK01002 100 mg BID, followed by a 3-day observation period then 100 mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mg	Experimental	Drug: LNK01002LNK01002 150 mg BID, followed by a 3-day observation period then 150 mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mg	Experimental	Drug: LNK01002LNK01002 200 mg BID, followed by a 3-day observation period then 200 mg BID in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mg	Experimental	Drug: LNK01002LNK01002 260 mg BID, followed by a 3-day observation period then 260 mg BID in 28-day treatment cycles
Patients with Acute Myeloid Leukemia With Mutant FLT3	Experimental	Drug: LNK01002LNK01002 at the RP2D dose in 28-day treatment cycles
Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3	Experimental	Drug: LNK01002LNK01002 at the RP2D dose in 28-day treatment cycles
Patients with Primary or Secondary Myelofibrosis,PV	Experimental	Drug: LNK01002LNK01002 at the RP2D dose in 28-day treatment cycles

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age: 18 years old or older, male or female.
Patients must have histologically or cytologically confirmed tumors of the following types.
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
Women of childbearing potential negative pregnancy test at screening. Female patients of childbearing potential, or male patients and their partners should agree to effective contraception from signing ICF until 6 months after the last dose of study drug.

Key exclusion criteria (17 listed)

Patients who meet any of the following exclusion criteria will be excluded from the clinical study:
Allergic to any component of LNK01002.
Serum total bilirubin greater than 1.5 times the upper limit of the normal (ULN) reference range, except patients diagnosed as Gilbert's disease
ALT or AST higher than 3 times the ULN reference range without hepatic involvement by leukemia, which are excluded if higher than 5 times the ULN
Glomerular filtration rate or estimated creatinine clearance < 50 mL/min according to the Cockcroft-Gault formula;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LNK01002Also: LNK-1000318LNK01002 will be administrated orally.	Drug	Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mg, Patients with Acute Myeloid Leukemia With Mutant FLT3, Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mg, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mg, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mg, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mg, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mg, Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mg, Patients with Primary or Secondary Myelofibrosis,PV

Primary outcome

Assessing the safety and tolerability of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Time frame: 31 days
Assessed by monitoring the frequency, duration and severity of adverse events and serious adverse events.
Assessing maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Time frame: 31 days
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) will be assessed based on the safety profile by the SRC
Assessing the preliminary antitumor activity of LNK01002
Time frame: 24 Weeks
The preliminary antitumor activity will be analyzed in patients with different types of malignant myeloid hematologic neoplasms by response rate using bone marrow and hematologic analyses (MF/AML) or by the MF Symptom Assessment Scale and spleen volume by MRI (MF).

7 secondary outcomes

Measurement of pharmacokinetic (PK) parameter, AUC, in MF, PV,PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Cmax, in MF, PV,PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Tmax, in MF, PV, PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, CL/F, in MF, PV, PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, T1/2, in MF, PV, PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, Vz/F, in MF, PV,PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15
Measurement of pharmacokinetic (PK) parameter, MRT, in MF, PV,PV-MF or ET-MF patients
Time frame: Day 1, Day 2, and Day 15

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Acute Myeloid Leukemia

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
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RecruitingPhase 1/2
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda Wei, M.D. study director

Lynk Pharmaceuticals Co., Ltd

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LNK01002 in people with Acute Myeloid Leukemia and Primary Myelofibrosis, run by Lynk Pharmaceuticals Co., Ltd at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing the safety and tolerability of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms (time frame: 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.