Clinical Trials /

Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL

NCT04542824

Description:

The purpose of the trial is to determine the maximum tolerated dose and/or the recommended phase 2 dose as well as to establish the safety profile of epcoritamab in Japanese patients with Relapsed, Progressive or Refractory B-Cell Lymphomas.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Follicular Lymphoma
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Nodal Marginal Zone Lymphoma
  • Primary Mediastinal B-Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL
  • Official Title: Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts

Clinical Trial IDs

  • ORG STUDY ID: GCT3013-04
  • NCT ID: NCT04542824

Conditions

  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Primary Mediastinal Large B Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
epcoritamabepcoritamab

Purpose

The purpose of the trial is to determine the maximum tolerated dose and/or the recommended phase 2 dose as well as to establish the safety profile of epcoritamab in Japanese patients with Relapsed, Progressive or Refractory B-Cell Lymphomas.

Detailed Description

      The trial is an open-label, multi-center safety trial of epcoritamab. The trial consists of
      two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2). The expansion
      part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been
      determined in Part 1.
    

Trial Arms

NameTypeDescriptionInterventions
epcoritamabExperimentalOpen label, single arm trial where epcoritamab will be administered
  • epcoritamab

Eligibility Criteria

        Main Inclusion Criteria:

          -  Must be at least 20 years of age, inclusive

          -  Asian race and Japanese ethnicity

          -  Documented CD20 positive mature B-cell neoplasm

               1. Part 1 - dose escalation:

                    -  Diffuse large B-cell lymphoma (de novo or histologically transformed)

                    -  High-grade B-cell lymphoma

                    -  Primary mediastinal large B-cell lymphoma

                    -  Follicular lymphoma

                    -  Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid
                       tissue, or splenic)

                    -  Small lymphocytic lymphoma

               2. Part 2 - expansion:

                    -  Diffuse large B-cell lymphoma (de novo or histologically transformed)

                    -  Follicular lymphoma grade 1-3A

          -  Relapsed or refractory disease and previously treated with at least 2 lines of
             systemic antineoplastic therapy including at least 1 anti-CD20 mAb-containing therapy.

          -  Measurable disease by CT, MRI or PET-CT scan

        Main Exclusion Criteria:

          -  Primary CNS lymphoma or CNS involvement by lymphoma

          -  Subjects not eligible for high dose therapy with autologous hematopoietic stem cell
             transplantation due to personal choice, social issues, or similar

          -  AST and/or ALT > 3 xULN

          -  Total bilirubin > 1.5 xULN (unless due to Gilbert syndrome)

          -  Creatinine clearance < 45 mL/min

          -  Known clinically significant cardiac disease

          -  Chronic ongoing infectious diseases requiring treatment (excluding prophylactic
             treatment)

          -  Exposed to live or live attenuated vaccine within 4 weeks before the first dose of
             epcoritamab

          -  Active hepatitis B (HepB DNA positive) or hepatitis C (HepC RNA positive)

          -  Known history or positive test results confirming HIV infection
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Escalation:Adverse Events (AEs) to determine the Recommended Phase 2 Dose (RP2D)
Time Frame:Adverse events are assessed during the first cycle (28 days) in each cohort
Safety Issue:
Description:• Number of AEs, treatment emergent AEs as assessed by CTCAE V5.0.

Secondary Outcome Measures

Measure:Escalation and Expansion: Pharmacokinetic parameters, Cmax
Time Frame:During the first cycle (28 days) for each patient
Safety Issue:
Description:• Peak Concentration (Cmax)
Measure:Escalation and Expansion: Pharmacokinetic parameters, AUC
Time Frame:During the first cycle (28 days) for each patient
Safety Issue:
Description:•Area under the concentration versus time curve (AUC)
Measure:Escalation and Expansion: Pharmacokinetic parameters, C trough
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•Trough Concentration
Measure:Escalation and Expansion: Anti-Drug-Antibodies (ADAs) to evaluate immunogenicity
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•ADAs
Measure:Escalation and Expansion: Safety laboratory parameters (hematology)
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•CTCAE Grade changes from Baseline of hematology parameters: Hemoglobin, hematocrit, white blood cells including differential, neutrophils, basophils, eosinophils, absolute and percentage of lymphocytes, monocytes, reticulocytes, platelets, proportion of prolymphocytes.
Measure:Escalation and Expansion: Safety laboratory parameters (biochemistry)
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•CTCAE Grade changes from baseline of biochemistry parameters: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, lactate dehydrogenase (LDH), calcium, chloride, magnesium, inorganic phosphorus (phosphate), sodium, potassium, creatinine, total bilirubin, blood urea nitrogen (BUN) or urea, uric acid, glucose, total protein, C reactive protein, D-dimer, ferritin.
Measure:Escalation and Expansion: Safety laboratory parameters (coagulation)
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•CTCAE Grade changes from Baseline of coagulation parameters: International normalized ratio (INR), activated partial thromboplastin time (aPTT), and fibrinogen.
Measure:Escalation and Expansion: Cytokine measures to evaluate safety and tolearability
Time Frame:During the first 3 cycles for each patient (each cycle is 28 days)
Safety Issue:
Description:•Plasma levels of cytokines
Measure:Expansion: AEs to evaluate safety and tolerability
Time Frame:Up to 3 years after last patient dosed in the trial, through study completion
Safety Issue:
Description:•Number of AEs, treatment emergent AEs as assessed by CTCAE V5.0.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genmab

Last Updated

September 2, 2020