First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

Part of paid clinical trials in Denver, Colorado.

Sponsor
Genmab
Study ID
NCT04358458
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • GEN3009 — BIOLOGICAL
    GEN3009 will be administered by intravenous (IV) infusion in cycles of 28 days
  • Epcoritamab — BIOLOGICAL
    Epcoritamab will be administered by subcutaneous (SC) injections in cycles of 28 days

Study Details

The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 ("escalation"), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 ("expansion").

Key Dates

Start date
Mar 13, 2020
Status verified
Oct 2024
Primary completion
Nov 21, 2022
Completion
Jul 28, 2023

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Arm
  • Experimental: Combination Arm

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: During the first treatment cycle (Cycle length=28 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
The University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98133-

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Colorado Blood Cancer Institute· Denver, COUniversity Hospitals Cleveland Medical Center· Cleveland, OHOhio State University· Columbus, OHMedical University of South Carolina (MUSC)· Charleston, SCThe University of Texas Southwestern Medical Center· Dallas, TXMD Anderson Cancer Center· Houston, TX

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