Polycythemia Vera (PV)Phase 1NCT07529951
Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers
A Phase 1 study testing ZE74-0282 in people with Polycythemia Vera (PV) and Myelofibrosis (MF), run by Eilean Therapeutics.
Trial summary
This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera (PV), Myelofibrosis (MF)
- What is being tested?
- ZE74-0282
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient has histological confirmation JAK2 V617F mutated hematologic diagnosis with later confirmation using ipsogen® JAK2 RGQ PCR Kit) with prior therapy or who have declined them.
- All AEs related to prior therapies (chemotherapy/systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline except for:
- Alopecia (Grade ≤2)
- Sensory neuropathy (Grade ≤2)
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- Other AEs that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the patient.
- Adequate hematologic function including
- Organ function/reserve as per the following laboratory criteria:
- Hepatic: Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin < 2 x ULN (except for patients with known or suspected Gilbert's syndrome and with direct bilirubin within normal range) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.
- Renal: Adequate renal function as defined by calculated creatinine clearance >45 mL/min for the local laboratory.
- Baseline corrected QT interval by Fredericia (QTcF) < 470 ms. Patients with right, left, or partial bundle branch blocks or pacemaker that may confound interpretation of this reading are not excluded from this provided they lack history of primary arrhythmic events and are cleared by cardiology for enrollment in the trial.
- Pregnancy:
- Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening (not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and/or hysterectomy). The test must be performed within 72 hours before Day 1 of treatment.
- Women of non-child-bearing potential must have at least 12 continuous months of natural (spontaneous) amenorrhea and an appropriate clinical profile (e.g., age appropriate or history of vasomotor symptoms) or have had surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) >42 days prior to screening.
- Contraception and Gamete Donation:
- Male patients with a WOCBP partner must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment.
- Women of child-bearing potential must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from ova donation from screening visit until 120 days following the last dose of study treatment.
- Written informed consent must be obtained according to local guidelines and signed and dated by the patient prior to the performance of any study specific procedures, sampling, or analyses.
Who cannot join
- Clinical signs/symptoms of leukostasis or thrombophilia require urgent therapy (phereses).
- Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.
- Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.
- Patients who have received an investigational agent (for any indication) <14 days prior the first dose of ZE74-0282; an investigational agent is one for which there is no approved indication by the United States (US) FDA or by the applicable regulatory authority in the country where the study is being conducted. Additionally, the first dose of ZE74-0282 should not occur before the shorter of 28 days or a period of 5 half-lives of the investigational drug; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.
- Systemic antineoplastic or radiotherapy <14 days prior to the first day of ZE74-0282 administration (Hydroxyurea is allowed prior to study to control counts and may be given during study until completion of cycle 2.
- Female patients who are pregnant, lactating, or planning to become pregnant or initiate breastfeeding.
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- Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities, stroke or transient ischemic attack within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction),
- Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.
- Patients with uncontrolled infection requiring parenteral therapy shall not be enrolled until infection is treated and brought under control (to minimum of requirement of oral antibiotics).
- Currently participating in or has planned participation in a study of another investigational agent or device.
- Active prior or concurrent malignancy. Such patients for whom the natural history of the malignancy or its treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational schedule are eligible for this study, if approved in writing by the sponsor. Examples of such malignancies include basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and early-stage prostate cancer undergoing watchful waiting. Patients with a completely treated prior malignancy and no evidence of disease for >2 years prior to the first dose of ZE74-0282 are eligible.
- Patient for whom MRI OR CT imaging of spleen can not be performed on the same imaging platform throughout the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Dose Finding Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ZE74-0282 in Select JAK2 V617F Mutated Hematologic Disorders
This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of anti-tumor activity. Participants will receive ZE74-0282 in one of several dose groups. The study is open-label, meaning both the doctor and the participant know which treatment is given. It will take place at multiple centers across different countries. Blood tests and regular check-ups will be done to monitor side effects and measure the effect on the disease.
Read the detailed description
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ZE74-0282 in patients with JAK2 V617F mutated hematologic malignancies who have received prior therapy or have declined available treatment options.
The study will be conducted in two parts:
Part 1 (Dose Escalation): Sequential cohorts of patients will receive escalating doses of ZE74-0282 to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE). Safety, tolerability, and PK will be assessed at each dose level.
Part 2 (Dose Expansion): Additional patients will be enrolled into several expansion cohorts at the MTD/RDE to further evaluate safety, tolerability, and preliminary anti-tumor activity in specific disease subtypes.
The study is expected to enroll approximately 60 patients. Adverse events will be graded according to CTCAE v6.0. Anti-tumor activity will be assessed using disease-specific response criteria.
- Conditions
- Polycythemia Vera (PV), Myelofibrosis (MF)
- Being tested
- ZE74-0282
- Keywords
- JAK2 V617F mutations, polycythemia vera, myelofibrosis
- Medical subject headings
- Polycythemia Vera, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZE74-0282Drug
Powder for suspension (sachets), oral, QD
| Study group | Role | What they receive |
|---|---|---|
| ZE74-0282 Dose Level -1 | Experimental | Optional and would only be performed Dose Level 1 is poorly tolerated. Receives: Drug: ZE74-0282 |
| ZE74-0282 Dose Level 1 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Dose Level 2 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Dose Level 3 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Dose Level 4 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Dose Level 5 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Selected dose 1 | Experimental | Not described Receives: Drug: ZE74-0282 |
| ZE74-0282 Selected dose 2 | Experimental | Not described Receives: Drug: ZE74-0282 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Recommended Phase 2 Dose
The recommended phase 2 dose (RP2D) will be defined based on the integrated review of efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) assessed in tandem across the dose expansion cohorts.
Measured: Through completion of the dose expansion phase (approximately 5 months)
Incidence of Dose-Limiting Toxicities
The incidence of dose-limiting toxicities (DLTs) assessed during Cycle 1 (from Day 1 to Day 28 of the first treatment cycle). DLTs will be graded according to CTCAE v6.0 and defined as specified in the protocol.
Measured: Cycle 1 (Day 1 through Day 28)
Secondary outcomes (23)
Incidence, Severity, and Duration of Treatment-Emergent Adverse Events
Incidence, severity, and duration of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE). Treatment-related TEAEs are defined as those with a reasonable possibility of being caused by the study drug.
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Serum Chemistry Abnormalities
Number of participants with clinically significant abnormalities in chemistry parameters (Sodium, Potassium, Chloride, Bicarbonate, Total protein, Albumin, Calcium, Magnesium, Phosphorus, Glucose, BUN or urea, Creatinine, Uric acid, Total bilirubin, LDH, AST, ALT, Alkaline phosphatase, CPK, Amylase, Lipase) assessed from baseline to end of treatment (EOT).
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Hematology Abnormalities
Number of participants with clinically significant abnormalities in hematology parameters, including but not limited to hemoglobin, white blood cell count, platelet count, and absolute neutrophil count.
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Coagulation Abnormalities
Number of participants with clinically significant abnormalities in coagulation parameters (Activated partial thromboplastin time, Fibrinogen, International normalised ratio/ Prothrombin time).
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Urinalysis Abnormalities
Number of participants with clinically significant abnormalities in urinalysis parameters (RBC, Glucose, Protein, Urine pH, Ketones, Bilirubin, Urine specific gravity, Blood).
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant ECG Abnormalities
Number of participants with clinically significant abnormalities on 12-lead electrocardiogram assessed from baseline to end of treatment including but not limited to the measurements of ventricular heart rate, PR interval, QRS duration, QT interval and QTcF.
Measured: From baseline up to Cycle 24 (28-day cycles).
Incidence of Grade ≥3 Adverse Events
Number of patients with adverse events of Grade 3 or higher (severe or medically significant but not immediately life-threatening; or life-threatening requiring urgent intervention; or death) assessed from baseline to end of treatment. All AEs will be graded according to the Common Terminology Criteria for Adverse Events ver. 6.0.
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Serious Adverse Events
Number of patients with serious adverse events, including events that result in death, are life-threatening, require hospitalization, cause significant disability, or are otherwise considered serious per ICH E6 guidelines.
Measured: From baseline up to Cycle 24 (28-day cycles)
Incidence of Treatment-Related Deaths
Number of patients with deaths considered by the investigator to be related (possibly, probably, or definitely) to the study drug. Treatment-related deaths are a subset of serious adverse events with outcome of death and a causal relationship to the investigational product.
Measured: From baseline up to Cycle 24 (28-day cycles)
Maximum Observed Plasma Concentration (Cmax) of ZE74-0282
Cmax is defined as the maximum observed plasma concentration of ZE74-0282 following study drug administration. Blood samples for PK analysis will be collected at specified time points on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 2 Day 2.
Measured: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Minimum Observed Plasma Concentration (Cmin) of ZE74-0282
Cmin is defined as the minimum observed plasma concentration of ZE74-0282 immediately prior to the next dose administration (trough concentration). Blood samples for PK analysis will be collected at specified time points on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 2 Day 2.
Measured: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Steady-State Plasma Concentration (Css) of ZE74-0282
Css is defined as the steady-state plasma concentration of ZE74-0282 achieved after repeated dosing. Blood samples for PK analysis will be collected at specified time points on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 2 Day 2.
Measured: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Area Under the Plasma Concentration-Time Curve (AUC) of ZE74-0282
AUC is defined as the area under the plasma concentration-time curve of ZE74-0282. Blood samples for PK analysis will be collected at specified time points on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 2 Day 2.
Measured: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Dose Proportionality of ZE74-0282 with Repeated Escalation
Dose proportionality will be assessed by evaluating the relationship between administered dose and systemic exposure parameters across escalating dose cohorts using a power model or analysis of variance. Blood samples for PK analysis will be collected at specified time points on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 2 Day 2.
Measured: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Partial Response or Complete Response
Number of patients who attain a best overall response of Partial Response (PR) or Complete Response (CR) as assessed by disease-specific response criteria.
Measured: From baseline up to Cycle 24 (28-day cycles).
Time to First Response and Time to Best Response
Among patients who achieve a response (Partial Response or Complete Response), the median time from start of study therapy to the first documented response (Time to First Response) and the median time from start of study therapy to the best response achieved (Time to Best Response) will be calculated. Response will be assessed using protocol-defined disease-specific criteria.
Measured: From baseline up to Cycle 24 (28-day cycles).
Duration of Response for Patients Achieving PR or CR
Among patients who achieve a response (Partial Response or Complete Response), the median duration of response will be calculated.
Measured: From baseline up to Cycle 24 (28-day cycles)
Median time from starting therapy until death
Median time from start of study therapy to death from any cause.
Measured: From baseline up to Cycle 24 (28-day cycles).
Change in JAK2 V617F Variant Allele Frequency (VAF) in Blood and Bone Marrow
Among treated patients, the median and range of maximum reduction from baseline in JAK2 V617F variant allele frequency will be assessed in peripheral blood and bone marrow samples collected during therapy.
Measured: From baseline up to Cycle 24 (28-day cycles)
Proportion of patients who eliminate V617F clone
Proportion of treated patients who achieve elimination of the JAK2 V617F mutant clone, defined as variant allele frequency (VAF) <0.02% in peripheral blood and/or bone marrow during therapy.
Measured: From baseline up to Cycle 24 (28-day cycles).
Change in Total Symptom Score
Change from baseline in Total Symptom Score (TSS) among treated patients.
Measured: From baseline up to Cycle 24 (28-day cycles).
Change in Bone Marrow Morphology Including Fibrosis
Change from baseline in bone marrow morphology, including assessment of marrow fibrosis grade.
Measured: From baseline up to Cycle 24 (28-day cycles)
Number of Patients Proceeding to Allogeneic Stem Cell Transplant
Number of patients enrolled in this study who proceed to allogeneic stem cell transplant at any time during or after study treatment.
Measured: From baseline up to Cycle 24 (28-day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia Vera (PV)Studies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eilean Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529951
- Sponsor's protocol ID
- ZE74-0282-0002
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ZE74-0282 in Select JAK2 V617F Mutated Hematologic Disorders
- ClinicalTrials.gov ID
- NCT07529951
- Acronym / sponsor ID
- ZE74-0282-0002
- Conditions
- Polycythemia Vera (PV), Myelofibrosis (MF)
- Keywords
- JAK2 V617F mutations, polycythemia vera, myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eilean TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (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.
This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of anti-tumor activity. Participants will receive ZE74-0282 in one of several dose groups. The study is open-label, meaning both the doctor and the participant know which treatment is given. It will take place at multiple centers across different countries. Blood tests and regular check-ups will be done to monitor side effects and measure the effect on the disease.
Detailed description
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ZE74-0282 in patients with JAK2 V617F mutated hematologic malignancies who have received prior therapy or have declined available treatment options.
The study will be conducted in two parts:
Part 1 (Dose Escalation): Sequential cohorts of patients will receive escalating doses of ZE74-0282 to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE). Safety, tolerability, and PK will be assessed at each dose level.
Part 2 (Dose Expansion): Additional patients will be enrolled into several expansion cohorts at the MTD/RDE to further evaluate safety, tolerability, and preliminary anti-tumor activity in specific disease subtypes.
The study is expected to enroll approximately 60 patients. Adverse events will be graded according to CTCAE v6.0. Anti-tumor activity will be assessed using disease-specific response criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ZE74-0282 Dose Level -1 | Experimental | Drug: ZE74-0282Optional and would only be performed Dose Level 1 is poorly tolerated. |
| ZE74-0282 Dose Level 1 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Dose Level 2 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Dose Level 3 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Dose Level 4 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Dose Level 5 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Selected dose 1 | Experimental | Drug: ZE74-0282 |
| ZE74-0282 Selected dose 2 | Experimental | Drug: ZE74-0282 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient has histological confirmation JAK2 V617F mutated hematologic diagnosis with later confirmation using ipsogen® JAK2 RGQ PCR Kit) with prior therapy or who have declined them.
- All AEs related to prior therapies (chemotherapy/systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline except for:
- Adequate hematologic function including
Key exclusion criteria (13 listed)
- Clinical signs/symptoms of leukostasis or thrombophilia require urgent therapy (phereses).
- Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.
- Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.
- Patients who have received an investigational agent (for any indication) <14 days prior the first dose of ZE74-0282; an investigational agent is one for which there is no approved indication by the United States (US) FDA or by the applicable regulatory authority in the country where the study is being conducted. Additionally, the first dose of ZE74-0282 should not occur before the shorter of 28 days or a period of 5 half-lives of the investigational drug; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.
- Systemic antineoplastic or radiotherapy <14 days prior to the first day of ZE74-0282 administration (Hydroxyurea is allowed prior to study to control counts and may be given during study until completion of cycle 2.
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 |
|---|---|---|
| ZE74-0282Powder for suspension (sachets), oral, QD | Drug | ZE74-0282 Dose Level -1, ZE74-0282 Dose Level 1, ZE74-0282 Dose Level 2, ZE74-0282 Dose Level 3, ZE74-0282 Dose Level 4, ZE74-0282 Dose Level 5, ZE74-0282 Selected dose 1, ZE74-0282 Selected dose 2 |
Primary outcome
Determination of the Recommended Phase 2 Dose
Time frame: Through completion of the dose expansion phase (approximately 5 months)
The recommended phase 2 dose (RP2D) will be defined based on the integrated review of efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) assessed in tandem across the dose expansion cohorts.
Incidence of Dose-Limiting Toxicities
Time frame: Cycle 1 (Day 1 through Day 28)
The incidence of dose-limiting toxicities (DLTs) assessed during Cycle 1 (from Day 1 to Day 28 of the first treatment cycle). DLTs will be graded according to CTCAE v6.0 and defined as specified in the protocol.
23 secondary outcomes
Incidence, Severity, and Duration of Treatment-Emergent Adverse Events
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Serum Chemistry Abnormalities
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Hematology Abnormalities
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Coagulation Abnormalities
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant Urinalysis Abnormalities
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Clinically Significant ECG Abnormalities
Time frame: From baseline up to Cycle 24 (28-day cycles).
Incidence of Grade ≥3 Adverse Events
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Serious Adverse Events
Time frame: From baseline up to Cycle 24 (28-day cycles)
Incidence of Treatment-Related Deaths
Time frame: From baseline up to Cycle 24 (28-day cycles)
Maximum Observed Plasma Concentration (Cmax) of ZE74-0282
Time frame: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Minimum Observed Plasma Concentration (Cmin) of ZE74-0282
Time frame: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Steady-State Plasma Concentration (Css) of ZE74-0282
Time frame: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Area Under the Plasma Concentration-Time Curve (AUC) of ZE74-0282
Time frame: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Dose Proportionality of ZE74-0282 with Repeated Escalation
Time frame: Cycle 1 (Days 1, 2, 8) and Cycle 2 (Days 1, 2).
Partial Response or Complete Response
Time frame: From baseline up to Cycle 24 (28-day cycles).
Time to First Response and Time to Best Response
Time frame: From baseline up to Cycle 24 (28-day cycles).
Duration of Response for Patients Achieving PR or CR
Time frame: From baseline up to Cycle 24 (28-day cycles)
Median time from starting therapy until death
Time frame: From baseline up to Cycle 24 (28-day cycles).
Change in JAK2 V617F Variant Allele Frequency (VAF) in Blood and Bone Marrow
Time frame: From baseline up to Cycle 24 (28-day cycles)
Proportion of patients who eliminate V617F clone
Time frame: From baseline up to Cycle 24 (28-day cycles).
Change in Total Symptom Score
Time frame: From baseline up to Cycle 24 (28-day cycles).
Change in Bone Marrow Morphology Including Fibrosis
Time frame: From baseline up to Cycle 24 (28-day cycles)
Number of Patients Proceeding to Allogeneic Stem Cell Transplant
Time frame: From baseline up to Cycle 24 (28-day cycles)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZE74-0282 in people with Polycythemia Vera (PV) and Myelofibrosis (MF), run by Eilean Therapeutics.
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 19 inclusion and 13 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Dokukina (+38269728309, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Recommended Phase 2 Dose (time frame: Through completion of the dose expansion phase (approximately 5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.