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NCT05552469 · ClinicalTrials.gov registry record · Phase 1
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
A Phase 1 study of Myeloid Diseases, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT05552469: Active Phase 1 study of Myeloid Diseases, sponsored by Novartis Pharmaceuticals.
NCT05552469 is a Phase 1 study of Myeloid Diseases that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05552469, a Phase 1 study of Myeloid Diseases, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as clinically relevant, occurring during the DLT monitoring period following the first administration of study treatment.
Conditions Studied
Interventions
- DRUG DFV890
Study Locations (20)
Other
- Novartis Investigative Site - Grenoble
- Novartis Investigative Site - Nantes
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Lübeck
- Novartis Investigative Site - Hong Kong
New York
- Weill Cornell Medicine NY-Presb - New York
- Memorial Sloan Kettering Cancer Ctr - New York
Saxony
- Novartis Investigative Site - Dresden
- Novartis Investigative Site - Leipzig
California
- Stanford Cancer Center - Stanford
Florida
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Illinois
- Northwestern University - Chicago
Maryland
- Sidney Kimmel CCC At JH - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 1 |
What the registry record for NCT05552469 still lists
NCT05552469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Myeloid Diseases appearing as the primary indexed condition, and to 1 intervention - of which DFV890 is the first listed.
NCT05552469 names 20 study sites across 14 states, led by Other, New York, Saxony.
Frequently Asked Questions
What is clinical trial NCT05552469 about?
NCT05552469 is a clinical study titled "Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases". Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics,...
What is the current status of trial NCT05552469?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2023-05-08. Estimated completion is 2027-02-01.
What conditions does trial NCT05552469 study?
This clinical trial studies the following conditions: Myeloid Diseases.
What interventions are being tested in trial NCT05552469?
The interventions under investigation include: DFV890 (DRUG).
Who is sponsoring clinical trial NCT05552469?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05552469 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05552469's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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