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.
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
| Drug | Synonyms | Arms |
|---|
| epcoritamab | | epcoritamab |
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
| Name | Type | Description | Interventions |
|---|
| epcoritamab | Experimental | Open label, single arm trial where epcoritamab will be administered | |
Eligibility Criteria
Main Inclusion Criteria:
- Must be at least 20 years of age, inclusive
- Japanese subjects
- 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
August 10, 2021
