BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)
Completed · Phase 1
Conditions studied: Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, B Cell Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Peripheral T Cell Lymphoma
In brief
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, 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 (RP2D) of BR101801 in subjects with relapsed/refractory B cell lymphoma, chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), and peripheral T cell lymphoma (PTCL). The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory Peripheral T-cell lymphoma(PTCL) at a dose of BR101801 identified in Phase Ia. Once the RP2D has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence.
Key facts
- Study ID
- NCT04018248
- Run by
- Boryung Pharmaceutical Co., Ltd
- People needed
- 26
- Starts
- 2020-04-21
- Expected to finish
- 2023-09-21
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Henry Ford Hospital — Detroit, Michigan, United States
- National Cancer Center — Goyang-si, Gyeonggi-do, South Korea
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea
- Inje University Busan Paik Hospital — Busan, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Seoul national university hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
Full record on ClinicalTrials.gov
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