Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)

Study Identifier
GCT3013-04
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Recruitment Complete
Sign up for trial alerts

Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Blood Cancer - Follicular Lymphoma (FL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Study Drug
  • Epcoritamab (monotherapy)
  • Epcoritamab
  • Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
  • Gemcitabine and oxaliplatin
  • Epcoritamab (maintenance)
  • Rituximab and lenalidomide
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    20+ years

    Protocol Summary

    The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants with relapsed, progressive or refractory B-cell lymphomas and Japanese participants with B-cell lymphomas that have achieved partial response (PR) or complete response (CR) following prior standard of care (SOC). The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2).

    The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in Japanese participants with relapsed, progressive or refractory B-cell lymphoma and Japanese participants with B-cell lymphomas that have achieved PR or CR.

    In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

    Part 2 of the trial will be initiated once the RP2D has been determined in Part 1. In Part 2, epcoritamab is investigated as a monotherapy and in combination with other SOC agents.

    Study Locations

    Location
    Status
    Location
    Tohoku University Hoaspital
    Sendai, Miyagi, Japan, 980-8577
    Status
    Not applicable
    Location
    Aichi Cancer Center Hospital
    Aichi, Japan
    Status
    Not applicable
    Location
    NHO Nagoya Medical Center
    Aichi, Japan
    Status
    Not applicable
    Location
    National Cancer Center Hospital East
    Chiba, Japan
    Status
    Not applicable
    Location
    Matsuyama Red Cross Hospital
    Ehime, Japan
    Status
    Not applicable
    Location
    National Hospital Organization Kyushu Cancer Center
    Fukuoka, Japan
    Status
    Not applicable
    Showing {first} - {last} of {total} Results