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NCT05496686 · ClinicalTrials.gov registry record · Phase 1
Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma
A Phase 1 study of Uveal Melanoma and Metastatic, sponsored by Modulation Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05496686: Recruiting Phase 1 study of Uveal Melanoma and Metastatic, sponsored by Modulation Therapeutics.
NCT05496686 is a Phase 1 study of Uveal Melanoma and Metastatic that is actively recruiting participants, run by Modulation Therapeutics. The registered enrollment target is 16 participants, below the 145-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05496686, a Phase 1 study of Uveal Melanoma and Metastatic, is actively recruiting participants, sponsored by Modulation Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of the study is to establish the maximum-tolerated dose (MTD) of 225Ac-MTI-201 in participants with metastatic uveal melanoma. The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanoma.
Primary Outcome
MTD will be determined by testing increasing doses up to 1327 microCi of 225Ac-MTI-201, administered as a single dose via IV on dose escalation cohorts 1 to 12 with 1 to 6 participants each. The MTD is reached when 6 patients receive the same highest tolerated dose of 225Ac-MTI-201. If dose-limiting toxicity (DLT) consistently occurs at the next higher dose of 225Ac-MTI-201, then 5 additional doses at the previous dose of 225Ac-MTI-201 will mark the end of clinical trial.
Conditions Studied
Interventions
- DRUG 4.7 microCi 225Ac-MTI-201
- DRUG 9.5 microCi of 225Ac-MTI-201
- DRUG 19 microCi of 225Ac-MTI-201
- DRUG 38 microCi of 225Ac-MTI-201
- DRUG 76 microCi of 225Ac-MTI-201
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-07-21 |
| Est. Completion | 2029-02-25 |
| Phase | Phase 1 |
What NCT05496686 shows while recruiting
NCT05496686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 145-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Uveal Melanoma appearing as the primary indexed condition, and to 5 interventions - of which 4.7 microCi 225Ac-MTI-201 is the first listed.
NCT05496686 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05496686 about?
NCT05496686 is a clinical study titled "Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma". The primary aim of the study is to establish the maximum-tolerated dose (MTD) of 225Ac-MTI-201 in participants with metastatic uveal melanoma. The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanom...
What is the current status of trial NCT05496686?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-07-21. Estimated completion is 2029-02-25.
What conditions does trial NCT05496686 study?
This clinical trial studies the following conditions: Uveal Melanoma, Metastatic.
What interventions are being tested in trial NCT05496686?
The interventions under investigation include: 4.7 microCi 225Ac-MTI-201 (DRUG), 9.5 microCi of 225Ac-MTI-201 (DRUG), 19 microCi of 225Ac-MTI-201 (DRUG), 38 microCi of 225Ac-MTI-201 (DRUG), 76 microCi of 225Ac-MTI-201 (DRUG).
Who is sponsoring clinical trial NCT05496686?
This trial is sponsored by Modulation Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05496686 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05496686's enrollment target sits among peer trials
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