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NCT04824794 · ClinicalTrials.gov registry record · Phase 1
GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies
A Phase 1 study, sponsored by Genmab.
- Terminated
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT04824794: Clinical Trial Phase 1 study, sponsored by Genmab.
NCT04824794 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 130 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04824794, a Phase 1 study, was terminated before completion, sponsored by Genmab.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed (disease has returned) or refractory (resistant to treatment) multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: 1. The Dose Escalation will test increasing doses of GEN3014 to identify a safe dose level to be tested in the other two parts. 2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 into the vein or daratumumab under the skin; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.
Primary Outcome
DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with seru
Interventions
- DRUG Daratumumab
- BIOLOGICAL GEN3014
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 1 |
Why NCT04824794 stopped before completion
NCT04824794 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Daratumumab is the first listed.
NCT04824794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04824794 about?
NCT04824794 is a clinical study titled "GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies". The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess ...
What is the current status of trial NCT04824794?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2021-03-09. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT04824794?
The interventions under investigation include: Daratumumab (DRUG), GEN3014 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04824794?
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 NCT04824794's enrollment target sits among peer trials
130 439th of 2000 higher than 1,550 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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