Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Boryung Pharmaceutical Co., Ltd
1. Phase Ia (Dose Escalation) Primary Objectives * To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL. * To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression. SecondaryObjectives * To characterize the plasma and urine PK of BR101801. * To assess the preliminary antitumor activity of BR101801. 2. Phase Ib (Dose Expansion) Primary Objectives • To assess the safety and tolerability of BR101801 at the RP2D dose in subjects with relapsed/refractory Peripheral T-cell lymphoma (PTCL). SecondaryObjectives * To assess clinical activity of BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression. * To assess the plasma PK of BR101801. OUTLINE: This is a Phase I, multi-center, open-label, FIH study. The safety monitoring committee(SMC) will be responsible for safety oversight.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
