Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Peripheral T-cell Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Patients will receive BR101801 capsules orally, QD in 28-day cycles. The regimen may be changed to BID dosing based on emerging data.

• Subjects with PTCL NOS, PTCL AITL, Nodal PTCL with TFH and PTCL FTCL

Phase Ia (dose escalation):25 mg capsules and 100 mg capsules Planned doses are 50, 100, 200, 325, and 450 mg.

BR101801 (Phase Ia)

Phase Ib (dose expansion):25 and 100 mg capsules Doses administered will be determined from Phase Ia data.

BR101801 (Phase Ib)

TM Kim, M.D, Ph.D

SJ Kim, M.D, Ph.D

DH Yoon, M.D, Ph.D

Jorge Chaves, M.D, Ph.D

Emily Curran, M.D, Ph.D

JS Kim, M.D, Ph.D

EY Lee, M.D, M.S

JO Lee, M.D, Ph.D

DH Yang, M.D, Ph.D

WS Lee, M.D, Ph.D

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.

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.

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

The recommended dose is determined by the number of patients who experience a dose limiting toxicity (DLT).

To evaluate safety and tolerability the aggregate review will include but is not limited to:

* CTCAE TEAEs, treatment-related TEAEs, Grade 3 or higher TEAEs, Grade 3 or higher treatment-related TEAEs, serious treatment-related TEAEs, and TEAEs leading to death.
* Laboratory results;
* Vital signs;
* ECGs;
* Physical examination
* ECOG performance status

Maximum concentration obtained directly from the observed concentration versus time data.

Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

Area under the plasma concentration-time curve from time zero during a dosing interval

Cumulative amount of unchanged drug excreted in urine

Boryung Pharmaceutical Co., Ltd

Spots Global Cancer Trial Database for br101801 (phase ia)