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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03625037
Registration number
NCT03625037
Ethics application status
Date submitted
7/06/2018
Date registered
10/08/2018
Date last updated
10/07/2025
Titles & IDs
Public title
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Scientific title
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Secondary ID [1]
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0
2017-001748-36
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Secondary ID [2]
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GCT3013-01
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Universal Trial Number (UTN)
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Trial acronym
EPCORE™ NHL-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
DLBCL
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High-grade B-cell Lymphoma (HGBCL)
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Primary Mediastinal Large B-cell Lymphoma (PMBCL)
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FL
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MCL
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Small Lymphocytic Lymphoma (SLL)
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Marginal Zone Lymphoma (MZL)
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Indolent B-cell Non-Hodgkin Lymphoma (iNHL)
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Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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0
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0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Other - Epcoritamab
Experimental: Epcoritamab - Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Treatment: Other: Epcoritamab
Administered as specified in the treatment arm.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose-Escalation: Dose Limiting Toxicity (DLT)
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Assessment method [1]
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To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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Timepoint [1]
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During the first cycle (28 days)
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Primary outcome [2]
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Dose-Escalation: Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
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Timepoint [2]
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From first dose until the end of the safety follow-up period (Up to 1 year)
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Primary outcome [3]
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Expansion: Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
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Timepoint [3]
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Up to 1.5 years
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Primary outcome [4]
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Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
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Assessment method [4]
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CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
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Timepoint [4]
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From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
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Secondary outcome [1]
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Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
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Assessment method [1]
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Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
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Timepoint [1]
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Up to 1 year
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Secondary outcome [2]
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Dose-Escalation: Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier as assessed by the investigator.
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Timepoint [2]
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Up to 1 year
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Secondary outcome [3]
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Expansion: DOR
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Assessment method [3]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria.
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Timepoint [3]
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Up to 1.5 years
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Secondary outcome [4]
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Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
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Assessment method [4]
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Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
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Timepoint [4]
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Up to 1.5 year
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Secondary outcome [5]
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
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Assessment method [5]
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CRS will be graded based on ASTCT criteria.
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Timepoint [5]
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Up to 1.5 years
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Secondary outcome [6]
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
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Assessment method [6]
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CRS will be graded based on ASTCT criteria.
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Timepoint [6]
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Up to 1.5 years
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Secondary outcome [7]
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Dose-OPT DLBCL and FL: ORR
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Assessment method [7]
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ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
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Timepoint [7]
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Up to 1.5 years
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Secondary outcome [8]
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Dose-OPT DLBCL and FL: CR Rate
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Assessment method [8]
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CR rate is defined as the percentage of participants with CR assessed by investigator.
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Timepoint [8]
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Up to 1.5 years
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Secondary outcome [9]
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Dose-OPT DLBCL and FL: Duration of CR (DoCR)
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Assessment method [9]
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
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Timepoint [9]
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Up to 1.5 years
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Secondary outcome [10]
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Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
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Assessment method [10]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
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Timepoint [10]
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Up to 1.5 years
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Secondary outcome [11]
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Dose-OPT DLBCL and FL: DLT
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Assessment method [11]
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To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
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Timepoint [11]
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During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
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Secondary outcome [12]
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Dose-OPT DLBCL, FL and MCL: DOR
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Assessment method [12]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
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Timepoint [12]
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Up to 1.5 years
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Secondary outcome [13]
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Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab
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Assessment method [13]
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Timepoint [13]
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Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days), up to approximately 1.5 years
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Secondary outcome [14]
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Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
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Assessment method [14]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria.
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Timepoint [14]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
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Secondary outcome [15]
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Expansion and Dose-OPT MCL: CR Rate
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Assessment method [15]
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CR rate is defined as the percentage of participants with CR based on Lugano criteria.
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Timepoint [15]
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Up to 1.5 years
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Secondary outcome [16]
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Expansion and Dose-OPT MCL: DoCR
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Assessment method [16]
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria.
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Timepoint [16]
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Up to 1.5 years
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Secondary outcome [17]
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Expansion and Dose-OPT MCL: ORR
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Assessment method [17]
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ORR is defined as the percentage of participants achieving CR or PR based on LYRIC.
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Timepoint [17]
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Up to 1.5 years
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Secondary outcome [18]
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Expansion: Time to Response (TTR)
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Assessment method [18]
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TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria.
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Timepoint [18]
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Up to 1.5 years
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Secondary outcome [19]
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Expansion and Dose-OPT MCL: CR Rate
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Assessment method [19]
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CR rate is defined as the percentage of participants with CR based on LYRIC.
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Timepoint [19]
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Up to 1.5 years
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Secondary outcome [20]
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Expansion and Dose-OPT MCL: PFS
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Assessment method [20]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC.
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Timepoint [20]
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Up to 1.5 years
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Secondary outcome [21]
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Expansion and Dose-OPT MCL: DOR
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Assessment method [21]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC.
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Timepoint [21]
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Up to 1.5 years
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Secondary outcome [22]
0
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Expansion and Dose-OPT MCL: DoCR
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Assessment method [22]
0
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC.
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Timepoint [22]
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Up to 1.5 years
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Secondary outcome [23]
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Expansion and Dose-OPT: TTR
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Assessment method [23]
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TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC.
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Timepoint [23]
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Up to 1.5 years
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Secondary outcome [24]
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Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
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Assessment method [24]
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0
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
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Timepoint [24]
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Up to 7 years and 6 months
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Secondary outcome [25]
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Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
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Assessment method [25]
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MRD is defined as percentage of participants with at least 1 MRD negative result.
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Timepoint [25]
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Up to 1.5 years
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Secondary outcome [26]
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All Parts: Number of Participants with CRS Events
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Assessment method [26]
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CRS will be graded based on ASTCT criteria.
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Timepoint [26]
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Up to Day 1 of Cycle 12 (Cycle length=28 days)
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Secondary outcome [27]
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All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)
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Assessment method [27]
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0
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Timepoint [27]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years
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Secondary outcome [28]
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All Parts: Area under Curve (AUC) of Epcoritamab
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Assessment method [28]
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0
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Timepoint [28]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years
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Secondary outcome [29]
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All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab
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Assessment method [29]
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Timepoint [29]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years
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Secondary outcome [30]
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All Parts: Time to Reach Cmax of Epcoritamab
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Assessment method [30]
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Timepoint [30]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years
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Secondary outcome [31]
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All Parts: Half Life of Epcoritamab (t1/2)
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Assessment method [31]
0
0
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Timepoint [31]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years
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Secondary outcome [32]
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All Parts: Number of Participants with Anti-drug Antibody (ADA)
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Assessment method [32]
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Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.
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Timepoint [32]
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Up to 7 years and 6 months
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Secondary outcome [33]
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All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
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Assessment method [33]
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TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.
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Timepoint [33]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
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Secondary outcome [34]
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All Parts: Overall survival (OS)
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Assessment method [34]
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OS is defined as the time from Day 1 of Cycle 1 to death.
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Timepoint [34]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years
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Secondary outcome [35]
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Expansion: Trough Concentration of Epcoritamab
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Assessment method [35]
0
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Timepoint [35]
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Up to 1.5 years
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Eligibility
Key inclusion criteria
Main Inclusion Criteria - Escalation Part (recruitment completed)
* Documented CD20+ mature B-cell neoplasm
1. DLBCL - de novo or transformed
2. HGBCL
3. PMBCL
4. FL
5. MCL
6. SLL
7. MZL (nodal, extranodal or mucosa associated)
* Relapsed 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.
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
* Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan
* Acceptable renal function.
* Acceptable liver function.
Main Inclusion Criteria - Expansion & Dose-OPT 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 Bruton's tyrosine kinase inhibitor [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 (HSCT) 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
* Aspartate aminotransferase (AST), and/or alanine transaminase (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 Creatinine clearance (CrCl) <45 milliliters (mL)/min.
* Known clinically significant cardiovascular disease.
* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (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 (deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]-positive) or hepatitis C (ribonucleic acid [RNA] PCR-positive infection). Participants with evidence of prior hepatitis B (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 Informed consent form (ICF).
* Pregnancy or breast feeding.
* Participant 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 participant.
* Contraindication to all uric acid lowering agents.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
666
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health - Clayton
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Recruitment hospital [2]
0
0
Concord Hospital - Concord
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Recruitment hospital [3]
0
0
St. Vincent Hospital - Fitzroy
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Recruitment hospital [4]
0
0
Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [5]
0
0
Royal Hobart Hospital RHH - Hobart
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Recruitment hospital [6]
0
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St. George Hospital - Kogarah
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Recruitment hospital [7]
0
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Cabrini Hospital - Malvern
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Recruitment hospital [8]
0
0
Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [9]
0
0
Gold Coast Hospital - Southport
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Recruitment hospital [10]
0
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
0
0
- Clayton
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Recruitment postcode(s) [2]
0
0
- Concord
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Recruitment postcode(s) [3]
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0
- Fitzroy
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Recruitment postcode(s) [4]
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0
- Herston
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Recruitment postcode(s) [5]
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0
- Hobart
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Recruitment postcode(s) [6]
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0
- Kogarah
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Recruitment postcode(s) [7]
0
0
- Malvern
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Recruitment postcode(s) [8]
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0
- Nedlands
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Recruitment postcode(s) [9]
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0
- Southport
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Recruitment postcode(s) [10]
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0
- Sydney
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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0
0
United States of America
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State/province [3]
0
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Colorado
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0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Iowa
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Michigan
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Nebraska
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0
0
United States of America
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State/province [9]
0
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New Jersey
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Country [10]
0
0
United States of America
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0
0
Ohio
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Country [11]
0
0
United States of America
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0
0
Oregon
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Pennsylvania
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Rhode Island
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Country [14]
0
0
United States of America
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State/province [14]
0
0
South Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Texas
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Country [16]
0
0
Canada
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State/province [16]
0
0
Calgary
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Country [17]
0
0
Canada
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State/province [17]
0
0
Toronto
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Country [18]
0
0
Denmark
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State/province [18]
0
0
Copenhagen
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Country [19]
0
0
Denmark
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State/province [19]
0
0
Odense
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0
0
Denmark
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State/province [20]
0
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Vejle
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Country [21]
0
0
Finland
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State/province [21]
0
0
Helsinki
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Seoul
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Lund
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Uppsala
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Plymouth
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Southampton
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Sutton
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Funding & Sponsors
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Commercial sector/industry
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Genmab
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Ethics approval
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Summary
Brief summary
The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the body does with epcoritamab once it is administered * What epcoritamab does to the body once it is administered * How well epcoritamab works against relapsed and/or refractory B-cell lymphoma 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 (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: * For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). * For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.
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Trial website
https://clinicaltrials.gov/study/NCT03625037
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Trial related presentations / publications
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. Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, Christensen JH, Hess B, Tilly H, Cordoba R, Lewis DJ, Okada C, Hutchings M, Clausen MR, Sancho JM, Cochrane T, Leppa S, Chamuleau MED, Gernhardt D, Altintas I, Liu Y, Ahmadi T, Dinh MH, Hoehn D, Favaro E, Elliott B, Thieblemont C, Vose JM. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Aug;11(8):e593-e605. doi: 10.1016/S2352-3026(24)00166-2. Epub 2024 Jun 15. 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.
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Public notes
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Contacts
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Genmab
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Thieblemont C, Phillips T, Ghesquieres H, Cheah CY...
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Journal
Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gya...
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Results not provided in
https://clinicaltrials.gov/study/NCT03625037
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