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This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia and Phase Ib).
The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RDE) of BR101801 in patients with relapsed/refractory advanced hematologic malignancies except acute leukemia and multiple myeloma.
The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory hematologic malignances at a dose of BR101801 identified in Phase Ia. Once the RDE has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence, and 3 groups will be recruited in parallel.
1. Phase Ia (Dose Escalation)
- 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.
- To characterize the plasma and urine PK of BR101801.
- To assess the preliminary antitumor activity of BR101801.
- To characterize the PD of BR101801.
- To explore BR101801 metabolites.
2. Phase Ib (Dose Expansion)
•To assess the safety and tolerability of BR101801 at the RDE dose in patients with relapsed and/or refractory B-cell lymphoma, CLL/SLL, and PTCL.
- 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
- To assess the PD of BR101801.
- To explore BR101801 metabolites.
OUTLINE:This is a Phase I, multi-center, open-label, FIH study . Patients in Phase Ia and Phase Ib will receive BR101801 capsules orally and safety monitoring committee (SMC) will be responsible for safety oversight.
Diffuse Large B Cell Lymphoma
BR101801 (Phase Ia), BR101801 (Phase Ib)
Not yet recruiting
Boryung Pharmaceutical Co., Ltd
Published on BioPortfolio: 2019-07-18T10:31:13-0400
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