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)

Sponsor
Genmab
Study ID
NCT04542824
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • High-grade B-cell Lymphoma
  • Marginal Zone Lymphoma
  • Primary Mediastinal Large B Cell Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 20, 2020
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
78 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Epcoritamab
    In participants with DLBCL/FL.
  • Experimental: Arm 2: Epcoritamab + Rituximab + Lenalidomide
    In participants with R/R FL
  • Experimental: Arm 3: Epcoritamab + Rituximab + Cyclophosphamide+ Doxorubicin+ Vincristine + Prednisone
    In participants with previously untreated DLBCL
  • Experimental: Arm 4: Epcoritamab + Gemcitabine + Oxaliplatin
    In participants with relapsed/refractory DLBCL
  • Experimental: Arm 5: Epcoritamab Maintenance
    In participants with FL in CR or in PR following 1L or 2L SOC treatment

Primary Outcome Measure

Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years ]

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