A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™NHL-1
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- STATUS
- Recruiting
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- End date
- Jul 1, 2025
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- participants needed
- 700
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- sponsor
- Genmab
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 Identifier | NCT03625037 |
| Sponsor | Genmab |
| Last Modified on | 27 October 2022 |
Eligibility
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