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First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1)

Primary Purpose

Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria Escalation Part (recruitment completed)

  • 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 and Optimization Parts

  • 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

NOTE: Other protocol defined Inclusion criteria may apply.

Main Exclusion Criteria Escalation, Expansion and Optimization Parts

  • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
  • Known past or current malignancy other than inclusion diagnosis
  • AST, and/or ALT >3 × upper limit of normal
  • Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Estimated CrCl <45 mL/min
  • Known clinically significant cardiovascular disease
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics)
  • Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration
  • Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue
  • Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation
  • Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in
  • Known human immunodeficiency virus (HIV) infection
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
  • Pregnancy or breast feeding
  • Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient
  • Contraindication to all uric acid lowering agents

Sites / Locations

  • Arizona Mayo ClinicRecruiting
  • University of California at San FranciscoRecruiting
  • Colorado Blood Cancer InstituteRecruiting
  • H. Lee Moffitt Cancer Center and Research InstituteRecruiting
  • Northside Hospital- The Blood Marrow Transplant Group
  • University of Iowa Hospital and ClinicsRecruiting
  • Ochsner Medical CenterRecruiting
  • University of MichiganRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Hackensack Meridian HealthRecruiting
  • Levine Cancer institute/ Atrium Health
  • The Cleveland Clinic FoundationRecruiting
  • OHSU Knight Cancer InstituteRecruiting
  • Hillman Cancer CenterRecruiting
  • Rhode Island HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Prisma Health- Upstate
  • UT SouthwesternRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer Center
  • Monash HealthRecruiting
  • Concord HospitalRecruiting
  • St. Vincent HospitalRecruiting
  • Integrated Clinical Oncology Network Pty Ltd (ICON)Recruiting
  • Royal Hobart Hospital RHHRecruiting
  • St. George HospitalRecruiting
  • Cabrini HospitalRecruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Gold Coast HospitalRecruiting
  • St George HospitalRecruiting
  • Tom Baker Cancer CareRecruiting
  • Toronto-Sunnybrook Regional Cancer Ctr
  • RigshospitaletRecruiting
  • Odense University HospitalRecruiting
  • Vejle HospitalRecruiting
  • Helsinki University HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • Tampere University HospitalRecruiting
  • Hopital Henri MondorRecruiting
  • Hopital Huriez-CHRU Lille
  • CHU MontpellierRecruiting
  • Hospital Saint-LouisRecruiting
  • Hospices Civils de Lyon Centre Hospitalier Lyon SudRecruiting
  • Centre Henri BecquerelRecruiting
  • CHU de Tours-Hopital BretonneauRecruiting
  • Institut Gustave Roussy
  • Charite - Universitaetsmedizin BerlinRecruiting
  • Klinik fur Innere Medizin Hamatologie and OnkologieRecruiting
  • Universitaetsklinikum KoelnRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Johannes Gutenberg UniversityRecruiting
  • Der Universität Munchen Medizinische Klinik III LMURecruiting
  • Ao Ss Antonio E Biagio AlessandriaRecruiting
  • Policlinico S. Orsola-Ematologia LA SeragnoliRecruiting
  • Istituto di Candiolo- Fondazione del Piemonte per l'OncologiaRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Dong-A University Hospital
  • Keimyung University Dongsan Medical Center
  • National Cancer Center
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University
  • VU University Medical CenterRecruiting
  • Maastricht University Medical Center
  • Erasmus MC Cancer InstituteRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Szpital Uniwersytecki nr 2 im dr. Jana BizielaRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pratia-McMRecruiting
  • Uniwersytet Medyczny w Lublinie
  • Wojewodzki Szpital Specjalistyczny im. Janusza KorczakaRecruiting
  • Maria Sklodowska-Curie Memorial Cancer Center and InstituteRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-RadeckiegoRecruiting
  • National University HospitalRecruiting
  • Singapore General HospitalRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital Universitario Vall dHebronRecruiting
  • Institut Catala de OncologiaRecruiting
  • Hospital Universitario Fundacin Jimnez DazRecruiting
  • Skåne University HospitalRecruiting
  • Karolinska University Hospital HuddingeRecruiting
  • Akademiska sjukhuset Uppsala University HospitalRecruiting
  • University Hospital of Wales
  • The Christie NHS Foundation TrustRecruiting
  • Plymouth University School of Medicine- Derriford HospitalRecruiting
  • University Hospital Southampton NHS Foundation Trust
  • Royal Marsden NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epcoritamab

Arm Description

Epcoritamab will be administered by subcutaneous injections in cycles of 28 days

Outcomes

Primary Outcome Measures

Escalation part: Incidence of Dose Limiting Toxicities (DLTs)
To determine the RP2D and the MTD, if reached.
Escalation part: Incidence and severity of Adverse Events (AEs)
Treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.
Expansion part: Objective Response Rate (ORR)
Defined as proportion of participants who have a partial or complete response (PR or CR) following treatment with epcoritamab. Determined by the Lugano response criteria, assessed by the Independent Review Committee (IRC).
Optimization part: Number of participants with cytokine release syndrome (CRS) events
Optimization part: Percentage of participants with =>Grade 2 CRS events

Secondary Outcome Measures

Escalation & Optimization parts: ORR
Defined as proportion of participants who have a PR or CR following treatment with epcoritamab. Determined by the Lugano response criteria.
Escalation phase: PR rate
Determined by the Lugano response criteria.
All parts: CR rate
Defined as proportion of participants with CR. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in expansion part is reviewed by the IRC.
Expansion part: Time to Response (TTR)
Defined as time to first documentation of objective tumor response (PR or better). Determined by the Lugano and LYRIC response criteria, assessed by the IRC.
All parts: Duration of Response (DOR)
Defined as time from first documentation of response (CR or PR) to the date of progression of disease (PD) or death, whichever occurs earlier. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in the expansion part is reviewed by the IRC.
Expansion & Optimization parts: Duration of CR (DoCR)
Defined as time from first documentation of CR to the date of PD or death, whichever occurs earlier. Determined by the Lugano and LYRIC response criteria, assessed by the IRC.
All parts: Time to next anti-lymphoma therapy (TTNT)
Calculated as time to date of initiation of new anti-lymphoma therapy.
All parts: Progression Free Survival (PFS)
Defined as time to first documented PD or death due to any cause. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in the expansion part is reviewed by the IRC.
All parts: Overall survival (OS)
Defined as time to death.
Optimization part: Incidence of DLTs
Optimization part: Number of participants with CRS events
Optimization part: Percentage of participants with =>Grade 2 CRS events
Optimization part: Number of participants with CRS events
Optimization part: Percentage of participants with =>Grade 2 CRS events
Expansion & Optimization parts: Incidence and severity of AEs
TEAEs as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.
All parts: Area-under-the-concentration-time curve from Time 0 to Time of last dose (AUClast)
All parts: AUC from Time 0 to Infinity (AUCinf)
All parts: Maximum (peak) plasma concentration (Cmax)
All parts: Time to reach Cmax (Tmax)
All parts: Pre-dose (trough) concentrations (Cthrough)
All parts: Elimination half-life (t 1/2)
All parts: Total body clearance of drug from the plasma (CL)
All parts: Volume of distribution (Vd)
All parts: Incidence of anti-drug antibodies (ADA)
Expansion & Optimization parts: Percentage of participants with Minimal Residual Disease (MRD) negativity status
Defined as proportion of participants with at least one MRD negative result.
Expansion & Optimization parts: Duration of MRD negative status
Defined as the number of days from the first documentation of MRD negative status to the date of MRD status change (not MRD negative).
Expansion part: Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Monitor change from baseline in health-related quality of life over time and in relation to treatment.

Full Information

First Posted
June 7, 2018
Last Updated
August 7, 2023
Sponsor
Genmab
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03625037
Brief Title
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Acronym
EPCORE™ NHL-1
Official Title
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: a dose-escalation part (Phase 1, first-in-human (FIH)) an expansion part (Phase 2a) a dose-optimization part (Phase 2a)
Detailed Description
The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in patients with relapsed, progressive or refractory B-cell lymphoma. In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab. The dose-optimization part will evaluate alternative priming and intermediate dose regimens of epcoritamab. All patients will receive epcoritamab at the RP2D.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
786 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epcoritamab
Arm Type
Experimental
Arm Description
Epcoritamab will be administered by subcutaneous injections in cycles of 28 days
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Escalation part: Incidence of Dose Limiting Toxicities (DLTs)
Description
To determine the RP2D and the MTD, if reached.
Time Frame
During the first cycle (28 days) in each cohort.
Title
Escalation part: Incidence and severity of Adverse Events (AEs)
Description
Treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.
Time Frame
From first dose until the end of the safety follow-up period (4 weeks after last dose)
Title
Expansion part: Objective Response Rate (ORR)
Description
Defined as proportion of participants who have a partial or complete response (PR or CR) following treatment with epcoritamab. Determined by the Lugano response criteria, assessed by the Independent Review Committee (IRC).
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Optimization part: Number of participants with cytokine release syndrome (CRS) events
Time Frame
From first dose until 7 days after second full dose (Day 28 for DLBCL/MCL; Day 35 for FL)
Title
Optimization part: Percentage of participants with =>Grade 2 CRS events
Time Frame
From first dose until 7 days after second full dose (Day 28 for DLBCL/MCL; Day 35 for FL)
Secondary Outcome Measure Information:
Title
Escalation & Optimization parts: ORR
Description
Defined as proportion of participants who have a PR or CR following treatment with epcoritamab. Determined by the Lugano response criteria.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Escalation phase: PR rate
Description
Determined by the Lugano response criteria.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
All parts: CR rate
Description
Defined as proportion of participants with CR. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in expansion part is reviewed by the IRC.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion part: Time to Response (TTR)
Description
Defined as time to first documentation of objective tumor response (PR or better). Determined by the Lugano and LYRIC response criteria, assessed by the IRC.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
All parts: Duration of Response (DOR)
Description
Defined as time from first documentation of response (CR or PR) to the date of progression of disease (PD) or death, whichever occurs earlier. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in the expansion part is reviewed by the IRC.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion & Optimization parts: Duration of CR (DoCR)
Description
Defined as time from first documentation of CR to the date of PD or death, whichever occurs earlier. Determined by the Lugano and LYRIC response criteria, assessed by the IRC.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
All parts: Time to next anti-lymphoma therapy (TTNT)
Description
Calculated as time to date of initiation of new anti-lymphoma therapy.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
All parts: Progression Free Survival (PFS)
Description
Defined as time to first documented PD or death due to any cause. Determined by the Lugano response criteria (both parts) and by the LYRIC response criteria (expansion part). Response/disease progression in the expansion part is reviewed by the IRC.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
All parts: Overall survival (OS)
Description
Defined as time to death.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Optimization part: Incidence of DLTs
Time Frame
From first dose until 7 days after second full dose (Day 28 for DLBCL/MCL; Day 35 for FL)
Title
Optimization part: Number of participants with CRS events
Time Frame
From Day 15 (DLBCL/MCL) or Day 22 (FL) until up to 1 year after the last participant's first dose
Title
Optimization part: Percentage of participants with =>Grade 2 CRS events
Time Frame
From Day 15 (DLBCL/MCL) or Day 22 (FL) until up to 1 year after the last participant's first dose
Title
Optimization part: Number of participants with CRS events
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Optimization part: Percentage of participants with =>Grade 2 CRS events
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion & Optimization parts: Incidence and severity of AEs
Description
TEAEs as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.
Time Frame
From first dose until the end of the safety follow-up period (60 days after last dose)
Title
All parts: Area-under-the-concentration-time curve from Time 0 to Time of last dose (AUClast)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: AUC from Time 0 to Infinity (AUCinf)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year.
Title
All parts: Maximum (peak) plasma concentration (Cmax)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Time to reach Cmax (Tmax)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Pre-dose (trough) concentrations (Cthrough)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Elimination half-life (t 1/2)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Total body clearance of drug from the plasma (CL)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Volume of distribution (Vd)
Time Frame
From first dose until treatment discontinuation, expected average of 1 year
Title
All parts: Incidence of anti-drug antibodies (ADA)
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion & Optimization parts: Percentage of participants with Minimal Residual Disease (MRD) negativity status
Description
Defined as proportion of participants with at least one MRD negative result.
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion & Optimization parts: Duration of MRD negative status
Description
Defined as the number of days from the first documentation of MRD negative status to the date of MRD status change (not MRD negative).
Time Frame
From first dose until up to 1 year after the last participant's first dose
Title
Expansion part: Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Description
Monitor change from baseline in health-related quality of life over time and in relation to treatment.
Time Frame
From first dose until up to 1 year after the last participant's first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria - Escalation Part (recruitment completed) Documented CD20+ mature B-cell neoplasm DLBCL - de novo or transformed HGBCL PMBCL FL MCL SLL MZL (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 & Optimization Parts Documented CD20 positive mature B cell neoplasm or CD20+ MCL DLBCL, de novo or transformed (including double hit or triple hit) PMBCL FL grade 3B Histologic confirmed FL MZL SLL MCL (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 Main Exclusion Criteria - All Parts Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening Known past or current malignancy other than inclusion diagnosis AST, and/or ALT >3 × upper limit of normal Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin Estimated CrCl <45 mL/min Known clinically significant cardiovascular disease Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy Seizure disorder requiring therapy (such as steroids or anti-epileptics) Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20 Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in Known human immunodeficiency virus (HIV) infection Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF Pregnancy or breast feeding Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient Contraindication to all uric acid lowering agents NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genmab Trial Information
Phone
+45 70202728
Email
clinicaltrials@genmab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieternella Lugtenburg, MD, PhD
Organizational Affiliation
Erasmus MC University Medical Center Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Hospital- The Blood Marrow Transplant Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer institute/ Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health- Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Withdrawn
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Monash Health
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Name
Concord Hospital
City
Concord
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. Vincent Hospital
City
Fitzroy
Country
Australia
Individual Site Status
Recruiting
Facility Name
Integrated Clinical Oncology Network Pty Ltd (ICON)
City
Herston
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital RHH
City
Hobart
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. George Hospital
City
Kogarah
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cabrini Hospital
City
Malvern
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gold Coast Hospital
City
Southport
Country
Australia
Individual Site Status
Recruiting
Facility Name
St George Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Care
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto-Sunnybrook Regional Cancer Ctr
City
Toronto
Country
Canada
Individual Site Status
Completed
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Huriez-CHRU Lille
City
Lille
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Henri Becquerel
City
Rouen cedex
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Tours-Hopital Bretonneau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Withdrawn
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik fur Innere Medizin Hamatologie and Onkologie
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Gutenberg University
City
Mainz
Country
Germany
Individual Site Status
Recruiting
Facility Name
Der Universität Munchen Medizinische Klinik III LMU
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ao Ss Antonio E Biagio Alessandria
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico S. Orsola-Ematologia LA Seragnoli
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
City
Candiolo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
VU University Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Erasmus MC Cancer Institute
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia-McM
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytet Medyczny w Lublinie
City
Lublin
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
City
Słupsk
Country
Poland
Individual Site Status
Recruiting
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall dHebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala de Oncologia
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacin Jimnez Daz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Akademiska sjukhuset Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Plymouth University School of Medicine- Derriford Hospital
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36548927
Citation
Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.
Results Reference
result
PubMed Identifier
34508654
Citation
Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
Results Reference
derived

Learn more about this trial

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

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