Spots Global Cancer Trial Database for BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)
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Trial Identification
Brief Title: BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)
Official Title: A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies
Study ID: NCT04018248
Study Description
Brief Summary: This is a Phase I-II, 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Henry Ford Hospital, Detroit, Michigan, United States
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul national university hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Contact Details
Name: TM Kim, M.D, Ph.D
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: SJ Kim, M.D, Ph.D
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: DH Yoon, M.D, Ph.D
Affiliation: Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Chaves, M.D, Ph.D
Affiliation: Northwest Medical Specialities, PLLC
Role: PRINCIPAL_INVESTIGATOR
Name: Emily Curran, M.D, Ph.D
Affiliation: University of Cincinnati
Role: PRINCIPAL_INVESTIGATOR
Name: JS Kim, M.D, Ph.D
Affiliation: Severance Hospital, Yonsei University Health System
Role: PRINCIPAL_INVESTIGATOR
Name: EY Lee, M.D, M.S
Affiliation: National Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: JO Lee, M.D, Ph.D
Affiliation: Seoul National University Bundang Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: DH Yang, M.D, Ph.D
Affiliation: Chonnam National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: WS Lee, M.D, Ph.D
Affiliation: Inje University
Role: PRINCIPAL_INVESTIGATOR
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