MedTrace Logo

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)

NCT04542824 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Genmab

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04542824 on ClinicalTrials.gov