Satara

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of oral AUR112 in patients with relapsed advanced lymphomas. This Phase 1, open-label, dose escalation study aims to assess the tolerability of AUR112 and determine the doses suitable for future trials. The study involves patients with relapsed Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease who have exhausted other effective therapies locally. Participants will receive AUR112 once daily, with dose escalation following a classic 3+3 design. Dose escalation continues until safety limits are reached or pharmacokinetic and pharmacodynamic data indicate a biologically active dose. The study monitors dose limiting toxicities and treatment-related adverse events, alongside detailed pharmacokinetic measurements at specified time points. During the study, participants will be closely monitored through clinical assessments and laboratory tests to evaluate safety and drug behavior in the body. Key outcomes include dose limiting toxicities within the first treatment cycle, adverse events graded by standard criteria, and pharmacokinetic parameters such as maximum concentration and half-life. The study also evaluates safety under fasting and fed conditions over a 28-day treatment cycle.