Clinical Trial: 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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Genmab |
| Information Provided By: | Genmab |
| Last Update Posted: | 2026-10-06 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Biological: Epcoritamab (monotherapy)
- Biological: Epcoritamab
- Drug: Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- Drug: Gemcitabine and oxaliplatin
- Biological: Epcoritamab (maintenance)
- Drug: Rituximab and lenalidomide
Other Study ID Numbers
- GCT3013-04
- JapicCTI-205408
- jRCT2080225312
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Genmab |
| Information Provided By: | Genmab |
| Last Update Posted: | 2026-10-06 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Biological: Epcoritamab (monotherapy)
- Biological: Epcoritamab
- Drug: Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- Drug: Gemcitabine and oxaliplatin
- Biological: Epcoritamab (maintenance)
- Drug: Rituximab and lenalidomide
Other Study ID Numbers
- GCT3013-04
- JapicCTI-205408
- jRCT2080225312