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NCT04358458 · ClinicalTrials.gov registry record · Phase 1
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
A Phase 1 study, sponsored by Genmab.
- Terminated
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04358458: Clinical Trial Phase 1 study, sponsored by Genmab.
NCT04358458 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04358458, a Phase 1 study, was terminated before completion, sponsored by Genmab.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
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").
Primary Outcome
DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hemato
Interventions
- BIOLOGICAL Epcoritamab
- BIOLOGICAL GEN3009
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-03-13 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 1 |
Why NCT04358458 stopped before completion
NCT04358458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Epcoritamab is the first listed.
NCT04358458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04358458 about?
NCT04358458 is a clinical study titled "First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas". 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...
What is the current status of trial NCT04358458?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2020-03-13. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT04358458?
The interventions under investigation include: Epcoritamab (BIOLOGICAL), GEN3009 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04358458?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04358458's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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