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)
EPCORE™ NHL-3
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
3 other identifiers
interventional
78
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2020
CompletedFirst Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
May 5, 2026
May 1, 2026
7 years
August 25, 2020
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
DLTs are assessed during the first cycle (28 days) in each cohort
Part 2, Arm 1: Objective Response Rate (ORR)
Up to 1.5 years
Part 2, Arms 2-4: Number of Participants with DLTs
DLTs are assessed during the first cycle (28 days) in arms 2-4
Part 2, Arms 2-5: Number of Participants with TEAEs
From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years
Secondary Outcomes (18)
Both parts: Area-under-the-concentration-time curve from Time 0 to Time of last dose (AUClast)
From first dose until treatment discontinuation, expected average of 1 year
Both parts: AUC from Time 0 to Infinity (AUCinf)
From first dose until treatment discontinuation, expected average of 1 year
Both parts: Maximum (Peak) Plasma Concentration (Cmax)
From first dose until treatment discontinuation, expected average of 1 year
Both parts: Time to Reach Cmax (Tmax)
From first dose until treatment discontinuation, expected average of 1 year
Both parts: Pre-dose (Trough) Concentrations (Cthrough)
From first dose until treatment discontinuation, expected average of 1 year
- +13 more secondary outcomes
Study Arms (5)
Arm 1: Epcoritamab
EXPERIMENTALIn participants with DLBCL/FL.
Arm 2: Epcoritamab + Rituximab + Lenalidomide
EXPERIMENTALIn participants with R/R FL
Arm 3: Epcoritamab + Rituximab + Cyclophosphamide+ Doxorubicin+ Vincristine + Prednisone
EXPERIMENTALIn participants with previously untreated DLBCL
Arm 4: Epcoritamab + Gemcitabine + Oxaliplatin
EXPERIMENTALIn participants with relapsed/refractory DLBCL
Arm 5: Epcoritamab Maintenance
EXPERIMENTALIn participants with FL in CR or in PR following 1L or 2L SOC treatment
Interventions
28-day cycle for Cycle 1 and then 56-day cycle from Cycle 2 through 13
28-day cycles.
Epcoritamab will be administered in combination with the respective SOC chemotherapy followed by epcoritamab monotherapy.
28-day cycles
Epcoritamab will be administered subcutaneously in cycles of 4 weeks (i.e. 28 days)
21-day cycles
Eligibility Criteria
You may qualify if:
- Must be at least 20 years of age, inclusive
- Japanese participants
- CD20 positivity at representative tumor biopsy
- Part 1:
- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic)
- Small lymphocytic lymphoma
- Part 2 :
- Arm 1:
- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- Follicular lymphoma grade 1-3A
- Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 monoclonal antibody (mAb)-containing therapy.
- +27 more criteria
You may not qualify if:
- Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
- Participants not eligible for high dose therapy with autologous hematopoietic stem cell transplantation due to personal choice, social issues, or similar
- Known clinically significant cardiac disease
- Chronic ongoing infectious diseases requiring treatment (excluding prophylactic treatment)
- Arm 2:
- FL Grade 3b
- Histologic evidence of transformation to an aggressive lymphoma
- Contraindication to rituximab or lenalidomide
- Unwilling or unable to take aspirin prophylaxis or prophylactic anticoagulant as clinically indicated
- Arm 3:
- Contraindication to any of the individual drugs of the R-CHOP regimen
- Arm 4:
- Contraindication to any of the individual drugs of the GemOx regimen
- Arm 5:
- FL Grade 3b
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Tohoku University Hoaspital
Sendai, Miyagi, 980-8577, 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
Related Publications (1)
Izutsu K, Akahane D, Toubai T, Saito T, Mishima Y, Fujisaki T, Nishikori M, Kumode T, Suehiro Y, Ishitsuka K, Conlon R, Takahashi A, D'Angelo Mansson B, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese patients with relapsed or refractory follicular lymphoma: primary results of the EPCORE NHL-3 trial. Leuk Lymphoma. 2025 Oct;66(10):1913-1921. doi: 10.1080/10428194.2025.2525983. Epub 2025 Jul 9.
PMID: 40632620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
September 9, 2020
Study Start
August 20, 2020
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share