NCT04542824

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)

Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All participants in the trial will receive epcoritamab, as monotherapy or in combination with SOC. The following regimens will be investigated in Part 2: Arm 1: epcoritamab monotherapy in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with R/R FL Arm 3: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated DLBCL with high risk features Arm 4: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL who either failed prior autologous hematopoietic stem cell transplantation (ASCT), or are ineligible for autologous HSCT. Arm 5: epcoritamab maintenance in participants with FL who achieve a CR or a PR following first line (1L)/second line (2L) SOC treatment

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Epcoritamab (monotherapy)	Epcoritamab will be administered subcutaneously in cycles of 4 weeks (i.e. 28 days)
BIOLOGICAL	Epcoritamab	Epcoritamab will be administered in combination with the respective SOC chemotherapy followed by epcoritamab monotherapy.
DRUG	Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone	21-day cycles
DRUG	Gemcitabine and oxaliplatin	28-day cycles
BIOLOGICAL	Epcoritamab (maintenance)	28-day cycle for Cycle 1 and then 56-day cycle from Cycle 2 through 13
DRUG	Rituximab and lenalidomide	28-day cycles.

Timeline

• Start date: 2020-08-20
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2020-09-09
• Last updated: 2026-04-08

Locations

15 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study