A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
The trial is an open-label, multi-center 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. 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.
Dose Escalation Objectives: Primary: -Determine maximum tolerated dose and recommended phase 2 dose Secondary: -Establish tolerability of GEN3013 -Establish PK profile after single and multiple doses -Evaluate immunogenicity -Evaluate anti-lymphoma activity Exploratory: -To evaluate biomarkers predictive of clinical response to GEN3013 -To evaluate pharmacodynamic markers linked to the mechanism of action of GEN3013 Expansion Objectives: Primary -To evaluate clinical efficacy as determined by Lugano criteria Secondary: -To further evaluate clinical efficacy as determined by Lugano criteria -To evaluate anti-lymphoma activity as determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) -To further evaluate clinical efficacy -To evaluate MRD status as a clinical efficacy endpoint -To evaluate safety and tolerability GEN3013 -To evaluate the PK and immunogenicity of GEN3013 -To evaluate patient-reported outcomes (PROs) related to lymphoma symptoms Exploratory: -To evaluate biomarkers predictive of clinical response to GEN3013 -To evaluate pharmacodynamic markers linked to the mechanism of action of GEN3013 -To evaluate PROs related to well-being and general health status
Main Inclusion Criteria Escalation Part
Expansion Exclusion Criteria:
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