Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers (NCT07529951) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers
60 participantsStarted 2026-05-15
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
✓. 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
Exclusion criteria
✕. Clinical signs/symptoms of leukostasis or thrombophilia require urgent therapy (phereses).
What they're measuring
1
Determination of the Recommended Phase 2 Dose
Timeframe: Through completion of the dose expansion phase (approximately 5 months)
✕. 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.
✕. 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),