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ACTIVE NOT RECRUITING
NCT04542824
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2020-08-20

Completion Date

2027-09

Last Updated

2026-04-08

Healthy Volunteers

No

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.

Locations (15)

Tohoku University Hoaspital

Sendai, Miyagi, Japan

Aichi Cancer Center Hospital

Aichi, Japan

NHO Nagoya Medical Center

Aichi, Japan

National Cancer Center Hospital East

Chiba, Japan

Matsuyama Red Cross Hospital

Ehime, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Kagoshima University Hospital

Kagoshima, Japan

Kyoto University Hospital

Kyoto, Japan

Kindai University Hospital

Osaka, Japan

Osaka University Hospital

Osaka, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

National Cancer Center Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan