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