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NCT05415072 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
A Phase 1 study of Metastatic Uveal Melanoma, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 11
- Study locations
NCT05415072: Active Phase 1 study of Metastatic Uveal Melanoma, sponsored by Novartis Pharmaceuticals.
NCT05415072 is a Phase 1 study of Metastatic Uveal Melanoma that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 66 participants, below the 128-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (48% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05415072, a Phase 1 study of Metastatic Uveal Melanoma, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Conditions Studied
Interventions
- DRUG DYP688
Study Locations (11)
Other
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Heidelberg
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Zurich
New York
- Columbia University Medical Center- New York Presbyterian Onc Dept - New York
- Memorial Sloane Kettering Cancer Center MSKCC - New York
Massachusetts
- Massachusetts General Hospital Hematology Oncology - Boston
New South Wales
- Novartis Investigative Site - Westmead
Victoria
- Novartis Investigative Site - Melbourne
South Holland
- Novartis Investigative Site - Leiden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-07-04 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 1 |
What the registry record for NCT05415072 still lists
NCT05415072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 128-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Metastatic Uveal Melanoma appearing as the primary indexed condition, and to 1 intervention - of which DYP688 is the first listed.
NCT05415072 lists 11 locations in 6 states (Other, New York, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05415072 about?
NCT05415072 is a clinical study titled "A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas". This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mut...
What is the current status of trial NCT05415072?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2022-07-04. Estimated completion is 2027-10-01.
What conditions does trial NCT05415072 study?
This clinical trial studies the following conditions: Metastatic Uveal Melanoma.
What interventions are being tested in trial NCT05415072?
The interventions under investigation include: DYP688 (DRUG).
Who is sponsoring clinical trial NCT05415072?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05415072 being conducted?
This trial has 11 study locations across Massachusetts, New York, New South Wales, Victoria, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05415072's enrollment target sits among peer trials
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