Phase 1 Study of Oral AUR108 for Safety and Dose Testing in Adults With Relapsed Advanced Lymphomas

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of an oral drug called AUR108 in adult patients with relapsed advanced lymphomas, including Non-Hodgkin and Hodgkin lymphoma. This Phase 1, open-label, first-in-human study focuses on patients who have no available curative or life-prolonging treatments left and have exhausted all effective local therapies. The study uses a traditional dose-escalation design to determine the best dose of AUR108 based on safety and biological data. Participants will receive AUR108 orally with doses planned at 50, 90, 150, 220, and 300 mg in a cycle of 3 days of dosing followed by 4 days off each week. The study follows a 33 dose-escalation method to evaluate safety and drug behavior in the body and to select the optimal biological dose. This is a multicenter trial with dose expansion planned after the initial dose-escalation phase. During the study, participants will be closely monitored for dose-limiting toxicities during the first 28-day cycle and treatment-related adverse events throughout the trial, which may last about a year. Researchers will collect blood samples to measure drug levels and effects at multiple time points, including days 1, 8, and 17. Participants will undergo safety assessments, organ function tests, and evaluations of their lymphoma status to track treatment impact and side effects over time.

A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)