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

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ClinicalTrials.gov Identifier: NCT03625037
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Biological: Epcoritamab Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : December 30, 2025


Arm Intervention/treatment
Experimental: Epcoritamab (GEN3013, DuoBody®-CD3xCD20)
Open label, single arm trial where Epcoritamab will be administered.
Biological: Epcoritamab
Epcoritamab will be administered in cycles of 4 weeks i.e. 28 days.




Primary Outcome Measures :
  1. Escalation: Adverse Events (safety) to determine the Recommended Phase 2 Dose RP2D [ Time Frame: Adverse Events are assessed during the first cycle (28 days) in each cohort. ]
    -Number of Adverse Events, treatment emergent AEs as assessed by CTCAE V5.0.

  2. Escalation: Tolerability to determine the RP2D. [ Time Frame: DLTs are assessed during the first cycle (28 days) in each cohort. ]
    -Number of Dose limiting toxicities DLTs.

  3. Expansion: Safety, Adverse Event AE Evaluation. [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -Total number of AEs and number of treatment emergent AEs as assessed by CTCAE V5.0.

  4. Expansion: Clinical Efficacy Evaluation. [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -Antitumor activity as measured by the objective response rate according to Lugano classification


Secondary Outcome Measures :
  1. Escalation and Expansion: Pharmacokinetic parameters Cmax [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -PK, peak plasma concentration through concentration and half life.

  2. Escalation and Expansion: Pharmacokinetic parameters AUC [ Time Frame: During the first 4 doses in each patient ]
    -Maximum concentration AUC 0-Clast, AUC 0-x and half life.

  3. Escalation and Expansion: Immunogenicity-Anti Drug Antibody. [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -ADA titers measured as positive or negative host immune response and compared to PK, safety and tumor response.

  4. Expansion: Evaluate Patient Reported Outcomes EQ-5D-3L. [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -EQ-5D-3L; a six item questionnaire measuring changes from baseline; item 1 addressing a summary of the 5 next being; mobility, self care, usual activity, pain/discomfort, anxiety depression. Measured on a scale from 0 to 100, 100 being best.

  5. Expansion: Evaluate Patient Reported Outcomes FACT-Lym. [ Time Frame: Until 1 year after last patient enters the trial, through study completion. ]
    -FACT-Lym is a 2 module quality of life questionnaire measuring changes from baseline. FACT-G for quality of life and Lym a lymphoma specific questionnaire both using by a 5 point scale 0-4, 4 being best.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria Escalation Part

  • Documented CD20+ mature B-cell neoplasm

    1. Diffuse large B-cell lymphoma - de novo or transformed
    2. High-grade B-cell lymphoma
    3. Primary mediastinal large B-cell lymphoma
    4. Follicular lymphoma
    5. Mantle cell lymphoma
    6. Small lymphocytic lymphoma
    7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)
  • Relapsed, progressive and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • ECOG performance status 0,1 or 2
  • Patients must have measurable disease by CT, MRI or PET-CT scan
  • Acceptable renal function
  • Acceptable liver function

Main Inclusion Criteria Expansion Part

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL
  • Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple hit)
  • Primary mediastinal large B cell lymphoma
  • Follicular lymphoma grade 3B
  • Histologic confirmed follicular lymphoma
  • Marginal zone lymphomas
  • Small lymphocytic lymphoma
  • Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)
  • At least 2 therapies including an anti CD20 monoclonal antibody containing chemotherapy combination regimen
  • Either failed prior autologous hematopoietic stem cell transplantation or ineligible for autologous stem cell transplantation due to age or comorbidities
  • At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625037


Contacts
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Contact: Genmab A/S Trial Information +45 70202728 clinicaltrials@genmab.com

Locations
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Sponsors and Collaborators
Genmab
AbbVie
Investigators
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Principal Investigator: Pieternella Lugtenburg, MD, PhD Erasmus MC University Medical Center Rotterdam
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Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT03625037    
Other Study ID Numbers: GCT3013-01
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia