NCT04018248

BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)

A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	BR101801 (Phase Ia)	Phase Ia (dose escalation):25 mg capsules and 100 mg capsules Planned doses are 50, 100, 200, 325, and 450 mg.
DRUG	BR101801 (Phase Ib)	Phase Ib (dose expansion):25 and 100 mg capsules Doses administered will be determined from Phase Ia data.

Timeline

• Start date: 2020-04-21
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2019-07-12
• Last updated: 2025-09-10

Locations

9 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study