History of Changes for Study: NCT03625037

GEN3013 (DuoBody®-CD3xCD20) Safety 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 (DuoBody®-CD3xCD20) Safety Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Official Title:	A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Secondary IDs:

Study Status


Record Verification:	August 2020
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:	August 20, 2020
Last Update Posted:	August 26, 2020 [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)
Enrollment:	386 [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 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 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 ECOG-performance status 0 or 1

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, Michigan
	University of Michigan [Recruiting] Ann Arbor, Michigan, United States, 48109 Contact:Contact: Tycel Phillips, Dr.
	United States, Ohio
	The Cleveland Clinic Foundation [Recruiting] Cleveland, Ohio, United States, 44195 Contact:Contact: Alex Mejia Garcia, Dr. mejiaga@ccf.org
	United States, Texas
	UT Southwestern [Recruiting] Dallas, Texas, United States, 75390 Contact:Contact: Farrukh Awan, Dr.
	Australia
	St George Hospital [Not yet recruiting] Sydney, Australia Contact:Contact: Shir Jing Ho, Dr.
	Canada
	Tom Baker Cancer Care [Not yet recruiting] Calgary, Canada Contact:Contact: Carolyn Owen, Dr.
	Regional Health Authority B [Not yet recruiting] Moncton, Canada Contact:Contact: Nizar Abdel-Samad, Dr.
	Toronto-Sunnybrook Regional Cancer Ctr [Not yet recruiting] Toronto, Canada Contact:Contact: Neil Berenstein, Dr.
	Denmark
	Rigshospitalet [Recruiting] Copenhagen, Denmark Contact:Contact: Martin Hutchings, Dr.
	Odense University hospital [Recruiting] Odense, Denmark, 5000 C Contact:Contact: Jacob Haaber
	Vejle Hospital [Recruiting] Vejle, Denmark Contact:Contact: Michael Clausen, Dr.
	France
	Hospital Saint-Louis [Not yet recruiting] Paris, France Contact:Contact: Catherine Thieblemont, Dr.
	Germany
	Charite - Universitaetsmedizin Berlin [Not yet recruiting] Berlin, Germany Contact:Contact: Martin Janz, Dr.
	Italy
	Irccs Ospedale San Raffaele [Not yet recruiting] Milano, Italy Contact:Contact: Andres MJJ Ferreri, Dr.
	Korea, Republic of
	Samsung Medical Center [Not yet recruiting] Seoul, Korea, Republic of Contact:Contact: Won-Seong Kim, Dr.
	Netherlands
	VU University Medical Center [Recruiting] Amsterdam, Netherlands
	Maastricht University Medical Center [Not yet recruiting] Maastricht, Netherlands, 6229 HX Contact:Contact: Marjolein Van der Poel, Dr.
	Erasmus MC Cancer Institute [Recruiting] Rotterdam, Netherlands Contact:Contact: Pieternella Lugtenburg, Dr.
	Universitair Medisch Centrum Utrecht [Recruiting] Utrecht, Netherlands
	Poland
	Szpital Uniwersytecki nr 2 im dr. Jana Biziela [Not yet recruiting] Bydgoszcz, Poland Contact:Contact: Jaroslaw Czyz, Dr.
	Singapore
	National University Hospital [Not yet recruiting] Singapore, Singapore Contact:Contact: Limei Michelle Poon, Dr.
	Spain
	Hospital Germans Trias I Pujol [Recruiting] Badalona, Spain Contact:Contact: Juan Manuel Sancho Cia, Dr.
	Hospital Universitario Vall dHebron [Recruiting] Barcelona, Spain Contact:Contact: Pau Abrisqueta, Dr.
	Hospital Universitario Fundacin Jimnez Daz [Recruiting] Madrid, Spain Contact:Contact: Raul Cordoba, Dr.
	Clinica Universidad de Navarra [Recruiting] Pamplona, Spain Contact:Contact: Carlos Panizo, Dr.
	Spain, Navarra
	Clinica Universidad de Navarra [Recruiting] Pamplona, Navarra, Spain, 31008 Contact:Contact: Carlos Panizi, Dr. cpanizo@unav.es
	United Kingdom
	University Hospital of Wales [Not yet recruiting] Cardiff, United Kingdom Contact:Contact: Nagah Elmusharaf, Dr.
	The Christie NHS Foundation Trust [Recruiting] Manchester, 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: