Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 46 participants.
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").
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04358458
The ClinicalTrials.gov registry entry for NCT04358458 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Epcoritamab is the first listed.
NCT04358458 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.