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)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

15 sites in 1 country.

About this study

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

Conditions

Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma

Being tested

Epcoritamab (monotherapy), Epcoritamab, Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, Gemcitabine and oxaliplatin, Epcoritamab (maintenance)

Medical subject headings

Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Epcoritamab (monotherapy)Biological

  Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

  Epcoritamab will be administered subcutaneously in cycles of 4 weeks (i.e. 28 days)

• EpcoritamabBiological

  Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

  Epcoritamab will be administered in combination with the respective SOC chemotherapy followed by epcoritamab monotherapy.

• Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneDrug

  Also called R-CHOP

  21-day cycles

• Gemcitabine and oxaliplatinDrug

  Also called GemOx

  28-day cycles

• Epcoritamab (maintenance)Biological

  Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

  28-day cycle for Cycle 1 and then 56-day cycle from Cycle 2 through 13

• Rituximab and lenalidomideDrug

  Also called R2

  28-day cycles.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

   Measured: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years

2. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

   Measured: DLTs are assessed during the first cycle (28 days) in each cohort

3. Part 2, Arm 1: Objective Response Rate (ORR)

   Measured: Up to 1.5 years

4. Part 2, Arms 2-4: Number of Participants with DLTs

   Measured: DLTs are assessed during the first cycle (28 days) in arms 2-4

5. Part 2, Arms 2-5: Number of Participants with TEAEs

   Measured: From first dose until the end of the safety follow-up period (60 days after last dose), up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Sep 2020
2. Study start20 Aug 2020
3. Primary completionSep 2027 (estimated)
4. Study completionSep 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
• More trials run by GenmabThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.