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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Genmab
Study ID
NCT03625037
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)
  • DLBCL
  • FL
  • High-grade B-cell Lymphoma (HGBCL)
  • Indolent B-cell Non-Hodgkin Lymphoma (iNHL)
  • MCL
  • Marginal Zone Lymphoma (MZL)
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — BIOLOGICAL
    Administered as specified in the treatment arm.

Study Details

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.

Key Dates

Start date
Jun 26, 2018
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
666 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab
    Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.

Primary Outcome Measure

Dose-Escalation: Dose Limiting Toxicity (DLT) [ Time Frame: During the first cycle (28 days) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Arizona Mayo ClinicPhoenixArizona85054-
University of California at San FranciscoSan FranciscoCalifornia94117-
Colorado Blood Cancer InstituteDenverColorado80218-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Ochsner Medical CenterNew OrleansLouisiana70121-
University of MichiganAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48334-
University of Nebraska Medical CenterOmahaNebraska68198-
Hackensack Meridian HealthHackensackNew Jersey07601-
The Cleveland Clinic FoundationClevelandOhio44195-
OHSU Knight Cancer InstitutePortlandOregon97210-
Hillman Cancer CenterPittsburghPennsylvania15232-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South CarolinaCharlestonSouth Carolina29425-
UT SouthwesternDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Arizona Mayo Clinic· Phoenix, AZUniversity of California at San Francisco· San Francisco, CAColorado Blood Cancer Institute· Denver, COH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLUniversity of Iowa Hospital and Clinics· Iowa City, IAOchsner Medical Center· New Orleans, LA

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