Phase 1 Study of Oral AUR112 to Evaluate Safety and Effects in Adults With Relapsed Advanced Lymphoma

What this Trial Is About

Researchers are conducting a Phase 1, open-label, dose escalation study to assess the safety, pharmacokinetics PK, and pharmacodynamics PD of an oral drug called AUR112 in patients with relapsed advanced lymphomas. This first-in-human trial aims to find safe and tolerable doses of AUR112 for future studies. The study is led by Aurigene Discovery Technologies Limited and focuses on patients with relapsed or refractory non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia CLL, or Hodgkin disease who have exhausted other effective therapies. Participants will receive AUR112 once daily at increasing dose levels ranging from 100 mg to 1200 mg. The dose escalation follows a classic 33 design, where safety and biological activity data guide dose increases. The study will continue increasing doses until safety limits are reached or biologically active doses are identified. This approach helps determine the most appropriate doses for future clinical trials. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over the first 28 days cycle 1. Researchers will also measure various PK parameters like maximum concentration, time to maximum concentration, and area under the curve on specific days. Assessments include laboratory tests, physical exams, and safety evaluations. The study will help identify doses for further research while ensuring participant safety throughout the trial period.

Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma