Phase 1 Study of AJ1-11095 in Adults with Myelofibrosis Refractory to JAK2 Inhibitors

The primary objective of this phase 1 study is to evaluate the safety and pharmacokinetics of AJ1-11095 in adults diagnosed with myelofibrosis who have previously failed treatment with a JAK2 inhibitor. Assessing these parameters is critical for establishing the tolerability profile and metabolic disposition of the investigational compound in a refractory patient population.

The study involves a total of 51 patients diagnosed with myelofibrosis. The population includes both males and females within the age ranges corresponding to the 3 and 4 categories. This cohort is classified as a vulnerable population. The sponsor did not provide specific information regarding lifestyle considerations or selection methodologies.

This Phase 1 clinical trial is designed to evaluate the effects of AJ1-11095 in adults diagnosed with myelofibrosis who have previously failed treatment with a JAK2 inhibitor. The research methodology involves a sequence of study visits beginning with a screening visit to determine eligibility. Following screening, participants proceed through scheduled follow-up visits to monitor clinical progress and safety. The study concludes with an end-of-study visit. The overall duration of participant involvement is determined by the specific clinical protocol, and early termination from the study may occur based on predefined clinical criteria. The estimated period for recruitment and study completion is from December 2025 to February 2027.

The assessment of efficacy in this study concerning myelofibrosis will be conducted in accordance with the clinical trial protocol. Specific parameters for evaluating therapeutic response have not been defined within the provided documentation.