A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™NHL-1

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    700
  • sponsor
    Genmab
Updated on 27 October 2022
ct scan
renal function
stem cell transplantation
chronic lymphocytic leukemia
lymphoma
rituximab
monoclonal antibodies
measurable disease
cell transplantation
combination chemotherapy
follicular lymphoma
monoclonal protein
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
refractory b-cell non-hodgkin lymphoma
pet/ct scan
marginal zone lymphoma
renal function tests
large b-cell lymphoma
high grade b-cell lymphoma
anti-cd20 monoclonal antibody

Summary

The trial is a global, multi-center safety trial of Epcoritamab, an antibody also known as GEN3013 (DuoBody®-CD3xCD20). The trial consists of three parts: a dose-escalation part (Phase 1, first-in-human (FIH)), an expansion part (Phase 2a) and a dose optimization part (Phase 2a)

Description

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 patients with relapsed, progressive or refractory B-Cell Lymphoma.

In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose optimization part will evaluate alternative priming and intermediate dose regimens of epcoritamab. All patients will receive Epcoritamab at the already established full dose.

Details
Condition Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma
Treatment GEN3013 (DuoBody®-CD3xCD20), Epcoritamab
Clinical Study IdentifierNCT03625037
SponsorGenmab
Last Modified on27 October 2022

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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