Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers
brief 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.
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.
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