History of Changes for Study: NCT03625037

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

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Study Record Versions

Version	Submitted Date	Changes
1	August 9, 2018	None (earliest Version on record)
2	August 14, 2018	Study Status
3	September 13, 2018	Study Status and Contacts/Locations
4	September 27, 2018	Contacts/Locations and Study Status
5	January 7, 2019	Contacts/Locations, Study Status and Eligibility
6	January 14, 2019	Contacts/Locations and Study Status
7	February 26, 2019	Contacts/Locations and Study Status
8	April 12, 2019	Study Status and Contacts/Locations
9	July 19, 2019	Study Status and Contacts/Locations
10	August 20, 2020	Contacts/Locations, Arms and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility and Sponsor/Collaborators
11	January 8, 2021	Contacts/Locations, Study Status and Study Design
12	February 11, 2021	Contacts/Locations, Study Status, Study Identification, Eligibility and Study Design
13	July 27, 2021	Study Status and Contacts/Locations
14	June 17, 2022	Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status, Study Description, Eligibility and Study Identification
15	October 18, 2022	Outcome Measures, Study Description, Study Status, Study Identification, Contacts/Locations, Eligibility and Study Design
16	February 7, 2023	Study Status
17	February 23, 2023	Study Status
18	March 27, 2023	Outcome Measures, Study Status, Study Identification, Study Description, Eligibility and Conditions
19	May 25, 2023	Study Status, References, Arms and Interventions and Study Description
20	May 30, 2023	Study Status and Study Identification
21	June 27, 2023	Study Status, Contacts/Locations and Study Design
22	August 7, 2023	Contacts/Locations, Study Status and Study Identification
23	January 2, 2024	Study Status
24	February 14, 2024	Outcome Measures, Contacts/Locations, Study Description, Study Status, Eligibility, Arms and Interventions, Study Design and Conditions
25	March 4, 2024	Study Status and Study Identification
26	March 25, 2024	Recruitment Status, Study Status, Contacts/Locations and Study Design
27	April 4, 2024	Study Status
28	May 6, 2024	Study Status and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GCT3013-01
Brief Title:	GEN3013 Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Official Title:	A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Secondary IDs:

Study Status


Record Verification:	February 2021
Overall Status:	Recruiting
Study Start:	June 26, 2018
Primary Completion:	January 30, 2022 [Anticipated]
Study Completion:	December 30, 2025 [Anticipated]

First Submitted:	June 7, 2018
First Submitted that Met QC Criteria:	August 9, 2018
First Posted:	August 10, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	February 11, 2021
Last Update Posted:	February 15, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Genmab
Responsible Party:	Sponsor
Collaborators:	AbbVie

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

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.

Conditions


Conditions:	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
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Sequential Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	486 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.

Outcome Measures


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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Main Inclusion Criteria Escalation Part Documented CD20+ mature B-cell neoplasm Diffuse large B-cell lymphoma - de novo or transformed High-grade B-cell lymphoma Primary mediastinal large B-cell lymphoma Follicular lymphoma Mantle cell lymphoma Small lymphocytic lymphoma 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

Contacts/Locations


Central Contact Person:	Genmab A/S Trial Information Telephone: +45 70202728 Email: clinicaltrials@genmab.com
Study Officials:	Pieternella Lugtenburg, MD, PhD Principal Investigator Erasmus MC University Medical Center Rotterdam
Locations:	United States, Arizona
	Arizona Mayo Clinic [Recruiting] Phoenix, Arizona, United States, 85054
	United States, California
	University of California at San Francisco [Recruiting] San Francisco, California, United States, 94117
	United States, Colorado
	MD Anderson Cancer Center [Not yet recruiting] Aurora, Colorado, United States, 80045
	Colorado Blood Cancer Institute [Recruiting] Denver, Colorado, United States, 80218
	United States, Florida
	H. Lee Moffitt Cancer Center and Research Institute [Not yet recruiting] Tampa, Florida, United States, 33612
	United States, Georgia
	Northside Hospital- The Blood Marrow Transplant Group [Not yet recruiting] Atlanta, Georgia, United States, 30309
	United States, Iowa
	University of Iowa Hospital and Clinics [Not yet recruiting] Iowa City, Iowa, United States, 52242
	United States, Louisiana
	Ochsner Medical Center [Recruiting] New Orleans, Louisiana, United States, 70121
	United States, Michigan
	University of Michigan [Recruiting] Ann Arbor, Michigan, United States, 48109
	Barbara Ann Karmanos Cancer Institute [Recruiting] Detroit, Michigan, United States, 48334
	United States, Nebraska
	University of Nebraska Medical Center [Not yet recruiting] Omaha, Nebraska, United States, 68198
	United States, New Jersey
	Hackensack Meridian Health [Recruiting] Hackensack, New Jersey, United States, 07601
	United States, North Carolina
	Levine Cancer institute/ Atrium Health [Not yet recruiting] Charlotte, North Carolina, United States, 28204
	United States, Ohio
	The Cleveland Clinic Foundation [Recruiting] Cleveland, Ohio, United States, 44195
	United States, Oregon
	OHSU Knight Cancer Institute [Not yet recruiting] Portland, Oregon, United States, 97210
	United States, Pennsylvania
	Hillman Cancer Center [Recruiting] Pittsburgh, Pennsylvania, United States, 15232
	United States, Rhode Island
	Rhode Island Hospital [Not yet recruiting] Providence, Rhode Island, United States, 02903
	United States, South Carolina
	Medical University of South Carolina [Not yet recruiting] Charleston, South Carolina, United States, 29425
	Prisma Health- Upstate [Recruiting] Greenville, South Carolina, United States, 29605
	United States, Texas
	UT Southwestern [Recruiting] Dallas, Texas, United States, 75390
	United States, Wisconsin
	University of Wisconsin Carbone Cancer Center [Not yet recruiting] Madison, Wisconsin, United States, 53705
	Australia
	Monash Health [Recruiting] Clayton, Australia
	Concord Hospital [Recruiting] Concord, Australia
	St. Vincent Hospital [Recruiting] Fitzroy, Australia
	Integrated Clinical Oncology Network Pty Ltd (ICON) [Recruiting] Herston, Australia
	Royal Hobart Hospital RHH [Recruiting] Hobart, Australia
	St. George Hospital [Recruiting] Kogarah, Australia
	Cabrini Hospital [Recruiting] Malvern, Australia
	Sir Charles Gairdner Hospital [Recruiting] Nedlands, Australia
	Gold Coast Hospital [Recruiting] Southport, Australia
	St George Hospital [Recruiting] Sydney, Australia
	Canada
	Tom Baker Cancer Care [Recruiting] Calgary, Canada
	Toronto-Sunnybrook Regional Cancer Ctr [Not yet recruiting] Toronto, Canada
	Denmark
	Rigshospitalet [Recruiting] Copenhagen, Denmark
	Odense University Hospital [Recruiting] Odense, Denmark, 5000 C
	Vejle Hospital [Recruiting] Vejle, Denmark
	Finland
	Helsinki University Hospital [Not yet recruiting] Helsinki, Finland
	Kuopio University Hospital [Not yet recruiting] Kuopio, Finland
	Tampere University Hospital [Not yet recruiting] Tampere, Finland
	France
	Hopital Henri Mondor [Recruiting] Créteil, France
	Hopital Huriez-CHRU Lille [Recruiting] Lille, France
	CHU Montpellier [Recruiting] Montpellier, France
	Hospital Saint-Louis [Recruiting] Paris, France
	Hospices Civils de Lyon Centre Hospitalier Lyon Sud [Recruiting] Pierre-Bénite, France
	Centre Henri Becquerel [Recruiting] Rouen cedex, France
	CHU de Tours-Hopital Bretonneau [Recruiting] Tours, France
	Institut Gustave Roussy [Not yet recruiting] Villejuif, France
	Germany
	Charite - Universitaetsmedizin Berlin [Not yet recruiting] Berlin, Germany
	Klinik fur Innere Medizin Hamatologie and Onkologie [Recruiting] Berlin, Germany
	Universitaetsklinikum Koeln [Not yet recruiting] Cologne, Germany
	Universitaetsklinikum Essen [Not yet recruiting] Essen, Germany
	Johannes Gutenberg University [Recruiting] Mainz, Germany
	Der Universität Munchen Medizinische Klinik III LMU [Not yet recruiting] München, Germany
	Italy
	Ao Ss Antonio E Biagio Alessandria [Not yet recruiting] Alessandria, Italy
	Policlinico S. Orsola-Ematologia LA Seragnoli [Not yet recruiting] Bologna, Italy
	Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia [Not yet recruiting] Candiolo, Italy
	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori [Not yet recruiting] Meldola, Italy
	IRCCS Ospedale San Raffaele [Not yet recruiting] Milan, Italy
	Korea, Republic of
	Dong-A University Hospital [Recruiting] Busan, Korea, Republic of
	Keimyung University Dongsan Medical Center [Recruiting] Daegu, Korea, Republic of
	National Cancer Center [Recruiting] Goyang-si, Korea, Republic of
	Chonbuk National University Hospital [Recruiting] Jeonju, Korea, Republic of
	Seoul National University Bundang Hospital [Recruiting] Seongnam-si, Korea, Republic of
	Asan Medical Center [Recruiting] Seoul, Korea, Republic of
	Samsung Medical Center [Recruiting] Seoul, Korea, Republic of
	Seoul National University Hospital [Recruiting] Seoul, Korea, Republic of
	Severance Hospital, Yonsei University [Recruiting] Seoul, Korea, Republic of
	Netherlands
	VU University Medical Center [Recruiting] Amsterdam, Netherlands
	Maastricht University Medical Center [Recruiting] Maastricht, Netherlands, 6229 HX Contact:Contact: Principal Investigator
	Erasmus MC Cancer Institute [Recruiting] Rotterdam, Netherlands
	Universitair Medisch Centrum Utrecht [Recruiting] Utrecht, Netherlands
	Poland
	Szpital Uniwersytecki nr 2 im dr. Jana Biziela [Recruiting] Bydgoszcz, Poland
	Uniwersyteckie Centrum Kliniczne [Not yet recruiting] Gdańsk, Poland
	Pratia-McM [Not yet recruiting] Kraków, Poland
	Uniwersytet Medyczny w Lublinie [Not yet recruiting] Lublin, Poland
	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka [Recruiting] Słupsk, Poland
	Maria Sklodowska-Curie Memorial Cancer Center and Institute [Not yet recruiting] Warszawa, Poland
	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego [Not yet recruiting] Wrocław, Poland
	Singapore
	National University Hospital [Recruiting] Singapore, Singapore
	Singapore General Hospital [Recruiting] Singapore, Singapore
	Spain
	Hospital Germans Trias i Pujol [Recruiting] Badalona, Spain
	Hospital Universitario Vall dHebron [Recruiting] Barcelona, Spain
	Institut Catala de Oncologia [Recruiting] Barcelona, Spain
	Hospital Universitario Fundacin Jimnez Daz [Recruiting] Madrid, Spain
	Spain, Navarra
	Clinica Universidad de Navarra [Recruiting] Pamplona, Navarra, Spain, 31008
	Sweden
	Skåne University Hospital [Not yet recruiting] Lund, Sweden
	Karolinska University Hospital Huddinge [Not yet recruiting] Stockholm, Sweden
	Akademiska sjukhuset Uppsala University Hospital [Not yet recruiting] Uppsala, Sweden
	United Kingdom
	University Hospital of Wales [Not yet recruiting] Cardiff, United Kingdom
	The Christie NHS Foundation Trust [Recruiting] Manchester, United Kingdom
	Plymouth University School of Medicine- Derriford Hospital [Recruiting] Plymouth, United Kingdom
	University Hospital Southampton NHS Foundation Trust [Recruiting] Southampton, United Kingdom
	Royal Marsden NHS Foundation Trust [Recruiting] Sutton, United Kingdom

IPDSharing


Plan to Share IPD:	No

References


Links:
Available IPD/Information: