Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEilean Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Alopecia (Grade ≤2)
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ZE74-0282
DrugPowder for suspension (sachets), oral, QD
Treatment groups
60 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: ZE74-0282 Dose Level -1Experimental treatment 1 intervention
Group B: ZE74-0282 Dose Level 1Experimental treatment 1 intervention
Group C: ZE74-0282 Dose Level 2Experimental treatment 1 intervention
Group D: ZE74-0282 Dose Level 3Experimental treatment 1 intervention
Group E: ZE74-0282 Dose Level 4Experimental treatment 1 intervention
Group F: ZE74-0282 Dose Level 5Experimental treatment 1 intervention
Group G: ZE74-0282 Selected dose 1Experimental treatment 1 intervention
Group H: ZE74-0282 Selected dose 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through completion of the dose expansion phase (approximately 5 months)2
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.
Time frame
Cycle 1 (Day 1 through Day 28)Secondary outcomes
1
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.
Time frame
From baseline up to Cycle 24 (28-day cycles)2
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).
Time frame
From baseline up to Cycle 24 (28-day cycles)3
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.
Time frame
From baseline up to Cycle 24 (28-day cycles)4
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).
Time frame
From baseline up to Cycle 24 (28-day cycles)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: