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

NCT04018248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • TM Kim, M.D, Ph.D · Seoul National University Hospital

  • SJ Kim, M.D, Ph.D · Samsung Medical Center

  • DH Yoon, M.D, Ph.D · Asan Medical Center

  • Jorge Chaves, M.D, Ph.D · Northwest Medical Specialities, PLLC

  • Emily Curran, M.D, Ph.D · University of Cincinnati

  • JS Kim, M.D, Ph.D · Severance Hospital, Yonsei University Health System

  • EY Lee, M.D, M.S · National Cancer Center

  • JO Lee, M.D, Ph.D · Seoul National University Bundang Hospital

  • DH Yang, M.D, Ph.D · Chonnam National University Hospital

  • WS Lee, M.D, Ph.D · Inje University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2023-09-21
Completion
2023-09-21
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018248 on ClinicalTrials.gov