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NCT04424641 · ClinicalTrials.gov registry record · Phase 1
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
A Phase 1 study, sponsored by Genmab.
- Terminated
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04424641: Clinical Trial Phase 1 study, sponsored by Genmab.
NCT04424641 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04424641, a Phase 1 study, was terminated before completion, sponsored by Genmab.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
Primary Outcome
The DLT was defined as Grade (G) \>= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for \>1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that cause
Interventions
- BIOLOGICAL GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2021-10-29 |
| Phase | Phase 1 |
Why NCT04424641 stopped before completion
NCT04424641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. is the first listed.
NCT04424641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04424641 about?
NCT04424641 is a clinical study titled "A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors". The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
What is the current status of trial NCT04424641?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-07-15. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT04424641?
The interventions under investigation include: GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. (BIOLOGICAL).
Who is sponsoring clinical trial NCT04424641?
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 NCT04424641's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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