GEN3013 Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Titre officiel

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

Sommaire:

The trial is an open-label, multi-centre safety trial of epcoritamab GEN3013 (DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a.

Description de l'essai

Primary Outcome:

  • Escalation: Adverse Events (safety) to determine the Recommended Phase 2 Dose RP2D
  • Escalation: Tolerability to determine the RP2D.
  • Expansion: Safety, Adverse Event AE Evaluation.
  • Expansion: Clinical Efficacy Evaluation.
Secondary Outcome:
  • Escalation and Expansion: Pharmacokinetic parameters Cmax
  • Escalation and Expansion: Pharmacokinetic parameters AUC
  • Escalation and Expansion: Immunogenicity-Anti Drug Antibody.
  • Expansion: Evaluate Patient Reported Outcomes EQ-5D-3L.
  • Expansion: Evaluate Patient Reported Outcomes FACT-Lym.
The purpose of the escalation part of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D) as well as to establish the safety profile of epcoritamab GEN3013 (DuoBody®-CD3xCD20) in patients with relapsed, progressive or refractory B-Cell Lymphoma. In the expansion part additional patients will be treated with epcoritamab with the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

Voir cet essai sur ClinicalTrials.gov

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