Relapsed Advanced Lymphomas Clinical Trial
Official title:
A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data. ;