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NCT07420959 · ClinicalTrials.gov registry record · Phase 1
ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia
A Phase 1 study, sponsored by Mayo Clinic.
- Not yet
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT07420959: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT07420959 is a Phase 1 study that has not yet begun recruiting, run by Mayo Clinic. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07420959, a Phase 1 study, has not yet begun recruiting, sponsored by Mayo Clinic.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).
Primary Outcome
MTD is defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose-limiting toxicity (DLT) definitions. An unacceptable dose level is one that induces DLT in at least one-third of patients (at least 2 of a maximum of 6 new patients). The MTD of ABBV-383 thus will be the highest tested dose level where at most one out of 6 patients treated have a reported DLT.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- BIOLOGICAL Etentamig
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2026-10-25 |
| Est. Completion | 2038-10-25 |
| Phase | Phase 1 |
What is known before NCT07420959 opens enrollment
NCT07420959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07420959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07420959 about?
NCT07420959 is a clinical study titled "ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia". This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 is a monoclonal antib...
What is the current status of trial NCT07420959?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2026-10-25. Estimated completion is 2038-10-25.
What interventions are being tested in trial NCT07420959?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Etentamig (BIOLOGICAL).
Who is sponsoring clinical trial NCT07420959?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07420959's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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