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

• ClinicalTrials.gov Identifier: NCT03625037
• Recruitment Status: Active, not recruiting
• First Posted: August 10, 2018
• Last Update Posted: April 5, 2024
• Sponsor: Genmab
• Collaborator: AbbVie
• Information provided by (Responsible Party): Genmab

Study Description

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.

Condition or disease	Intervention/treatment	Phase
DLBCL; High-grade B-cell Lymphoma (HGBCL); Primary Mediastinal Large B-cell Lymphoma (PMBCL); FL; MCL; Small Lymphocytic Lymphoma (SLL); Marginal Zone Lymphoma (MZL)	Biological: Epcoritamab	Phase 1; Phase 2

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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 participants with relapsed or refractory B-cell lymphoma.

In the expansion part, additional participants 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-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:

• Diffuse large B-cell lymphoma (DLBCL)
• Follicular lymphoma (FL)
• Mantle cell lymphoma (MCL)

All participants will receive epcoritamab at the RP2D.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 666 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
• Actual Study Start Date: June 26, 2018
• Estimated Primary Completion Date: March 2025
• Estimated Study Completion Date: January 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: Epcoritamab; Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.	Biological: Epcoritamab; Administered as specified in the treatment arm.; Other Names: GEN3013; DuoBody®-CD3xCD20; EPKINLY™

Outcome Measures

Primary Outcome Measures :

1. Dose-Escalation: Dose Limiting Toxicity (DLT) [ Time Frame: During the first cycle (28 days) in each Dose-OPT Part DLBCL, FL and MCL ]
   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.
2. Dose-Escalation: Number of Participants with Adverse Events (AEs) [ Time Frame: From first dose until the end of the safety follow-up period (Up to 1 year) ]
   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.
3. Expansion and Dose-OPT MCL: Overall Response Rate (ORR) [ Time Frame: Up to 1.5 years ]
   ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria as assessed by independent review committee (IRC).
4. Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events [ Time Frame: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL) ]
   CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Secondary Outcome Measures :

1. Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab [ Time Frame: Up to 1 year ]
   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).
2. Dose-Escalation: DOR [ Time Frame: Up to 1 year ]
   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 as assessed by the investigator.
3. Expansion: DOR [ Time Frame: Up to 1.5 years ]
   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 IRC.
4. Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) [ Time Frame: Up to 1.5 year ]
   Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
5. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose [ Time Frame: Up to 1.5 years ]
   CRS will be graded based on ASTCT criteria.
6. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall [ Time Frame: Up to 1.5 years ]
   CRS will be graded based on ASTCT criteria.
7. Dose-OPT DLBCL and FL: ORR [ Time Frame: Up to 1.5 years ]
   ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
8. Dose-OPT DLBCL and FL: CR Rate [ Time Frame: Up to 1.5 years ]
   CR rate is defined as the percentage of participants with CR assessed by investigator.
9. Dose-OPT DLBCL and FL: Duration of CR (DoCR) [ Time Frame: Up to 1.5 years ]
   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.
10. Dose-OPT DLBCL and FL: Progression-Free Survival (PFS) [ Time Frame: Up to 1.5 years ]
    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.
11. Dose-OPT DLBCL and FL: DLT [ Time Frame: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL) ]
    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.
12. Dose-OPT MCL: Time to Complete Response (TTCR) [ Time Frame: Up to 1.5 years ]
    TTCR is defined as the time from Day 1 of Cycle 1 to first documentation of complete response based on Lugano criteria and LYRIC as assessed by IRC.
13. Dose-OPT DLBCL, FL and MCL: DOR [ Time Frame: Up to 1.5 years ]
    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.
14. Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
15. Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS [ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years ]
    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 assessed by IRC.
16. Expansion and Dose-OPT MCL: CR Rate [ Time Frame: Up to 1.5 years ]
    CR rate is defined as the percentage of participants with CR based on Lugano criteria as assessed by IRC.
17. Expansion and Dose-OPT MCL: DoCR [ Time Frame: Up to 1.5 years ]
    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 as assessed by IRC.
18. Expansion and Dose-OPT MCL: ORR [ Time Frame: Up to 1.5 years ]
    ORR is defined as the percentage of participants achieving CR or PR based on lymphoma response to immunomodulatory therapy criteria (LYRIC) as assessed by IRC.
19. Expansion and Dose-OPT MCL: Time to Response (TTR) [ Time Frame: Up to 1.5 years ]
    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 as assessed by IRC.
20. Expansion and Dose-OPT MCL: CR Rate [ Time Frame: Up to 1.5 years ]
    CR rate is defined as the percentage of participants with CR based on LYRIC as assessed by IRC.
21. Expansion and Dose-OPT MCL: PFS [ Time Frame: Up to 1.5 years ]
    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 assessed by IRC.
22. Expansion and Dose-OPT MCL: DOR [ Time Frame: Up to 1.5 years ]
    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 assessed by IRC.
23. Expansion and Dose-OPT MCL: DoCR [ Time Frame: Up to 1.5 years ]
    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 as assessed by IRC.
24. Expansion and Dose-OPT MCL: TTR [ Time Frame: Up to 1.5 years ]
    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 as assessed by IRC.
25. Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs [ Time Frame: Up to 7 years and 6 months ]
    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.
26. Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to 1.5 years ]
    MRD is defined as percentage of participants with at least 1 MRD negative result.
27. All Parts: Number of Participants with CRS Events [ Time Frame: Up to Day 1 of Cycle 12 (Cycle length=28 days) ]
    CRS will be graded based on ASTCT criteria.
28. All Parts: Immunophenotyping for Absolute T-cell and B-cell [ Time Frame: Up to Day 1 of Cycle 12 (Cycle length=28 days) ]
    Number of cells will be reported for absolute T-cells and B-cells.
29. All Parts: T-Cell Activation and Exhaustion Marker [ Time Frame: Up to 7 years and 6 months ]
    T-Cell Activation and Exhaustion Marker (CD69, CD25, and PD-1) will be measured using flow cytometry.
30. All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL) [ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]
31. All Parts: Area under Curve (AUC) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]
32. All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]
33. All Parts: Time to Reach Cmax of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]
34. All Parts: Half Life of Epcoritamab (t1/2) [ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]
35. All Parts: Number of Participants with Anti-drug Antibody (ADA) [ Time Frame: Up to 7 years and 6 months ]
    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.
36. All Parts: Time to Next Anti-lymphoma Therapy (TTNT) [ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years ]
    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.
37. All Parts: Overall survival (OS) [ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years ]
    OS is defined as the time from Day 1 of Cycle 1 to death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 CT, 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 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 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 Creatinine clearance (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). Participants 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 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.

Contacts and Locations

Locations

United States, Arizona

Arizona Mayo Clinic

Phoenix, Arizona, United States, 85054

United States, California

University of California at San Francisco

San Francisco, California, United States, 94117

United States, Colorado

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

United States, Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

United States, Iowa

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States, 52242

United States, Louisiana

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48334

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, New Jersey

Hackensack Meridian Health

Hackensack, New Jersey, United States, 07601

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97210

United States, Pennsylvania

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Texas

UT Southwestern

Dallas, Texas, United States, 75390

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Australia

Monash Health

Clayton, Australia

Concord Hospital

Concord, Australia

St. Vincent Hospital

Fitzroy, Australia

Royal Brisbane and Women's Hospital

Herston, Australia

Royal Hobart Hospital RHH

Hobart, Australia

St. George Hospital

Kogarah, Australia

Cabrini Hospital

Malvern, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Gold Coast Hospital

Southport, Australia

Westmead Hospital

Sydney, Australia

Canada

Tom Baker Cancer Care

Calgary, Canada

Toronto-Sunnybrook Regional Cancer Ctr

Toronto, Canada

Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark, 5000 C

Vejle Hospital

Vejle, Denmark

Finland

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Tampere University Hospital

Tampere, Finland

France

Hopital Henri Mondor

Créteil, France

CHU Montpellier

Montpellier, France

Hospital Saint-Louis

Paris, France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre Henri Becquerel

Rouen cedex, France

CHU de Tours-Hopital Bretonneau

Tours, France

Germany

Charite - Universitaetsmedizin Berlin

Berlin, Germany

Klinik fur Innere Medizin Hamatologie and Onkologie

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Essen

Essen, Germany

Johannes Gutenberg University

Mainz, Germany

Der Universität Munchen Medizinische Klinik III LMU

München, Germany

Italy

Ao Ss Antonio E Biagio Alessandria

Alessandria, Italy

Policlinico S. Orsola-Ematologia LA Seragnoli

Bologna, Italy

Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

Candiolo, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Korea, Republic of

Dong-A University Hospital

Busan, Korea, Republic of

Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of

National Cancer Center

Goyang-si, Korea, Republic of

Chonbuk National University Hospital

Jeonju, Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Severance Hospital, Yonsei University

Seoul, Korea, Republic of

Netherlands

VU University Medical Center

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

Erasmus MC Cancer Institute

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Poland

Szpital Uniwersytecki nr 2 im dr. Jana Biziela

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdańsk, Poland

Pratia-McM

Kraków, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, Poland

Maria Sklodowska-Curie Memorial Cancer Center and Institute

Warszawa, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wrocław, Poland

Singapore

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Spain

Clinica Universidad de Navarra

Pamplona, Navarra, Spain, 31008

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Universitario Vall dHebron

Barcelona, Spain

Institut Catala de Oncologia

Barcelona, Spain

Hospital Universitario Fundacin Jimnez Daz

Madrid, Spain

Sweden

Skåne University Hospital

Lund, Sweden

Karolinska University Hospital Huddinge

Stockholm, Sweden

Akademiska sjukhuset Uppsala University Hospital

Uppsala, Sweden

United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Plymouth University School of Medicine- Derriford Hospital

Plymouth, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Sponsors and Collaborators

Genmab

AbbVie

Investigators

• Study Director: Study Official; Genmab

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Genmab
• ClinicalTrials.gov Identifier: NCT03625037
• Other Study ID Numbers: GCT3013-01; 2017-001748-36 ( EudraCT Number ); NL64317.078.17 ( Registry Identifier: CCMO ); 241053 ( Other Identifier: IRAS ID; UK Research Summaries Database ); 2023-504802-12-00 ( Registry Identifier: EU CTIS )
• First Posted: August 10, 2018
• Last Update Posted: April 5, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes