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NCT07287397 · ClinicalTrials.gov registry record · Phase 1
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by Vector Y Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 11
- Study locations
NCT07287397 is a Phase 1 study of Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Vector Y Therapeutics. The registered enrollment target is 12 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 7 states.
The verdict
NCT07287397, a Phase 1 study of Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Vector Y Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 11
- Study locations
Study Summary
PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS). Two escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screening procedures.
Conditions Studied
Interventions
- GENETIC VTx-002
- DRUG Optional Rescue medication - Corticosteroids: Methylprednisolone
Study Locations (11)
Other
- UZ Leuven - Leuven
- UMC Utrecht - Utrecht
- Kings College Hospital - London
- Royal Hallamshire Hospital - Sheffield
Florida
- Mayo Clinic in Florida - Jacksonville
- University of Miami School of Science - Miami
Arizona
- St Joseph's Hospital and medical Center - Barrow Neurological Institute - Phoenix
California
- University of California San Diego Medical Center - San Diego
Massachusetts
- Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital - Boston
New York
- Herbert Irving Comprehensive Cancer Center - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-12-19 |
| Est. Completion | 2027-10-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07287397
The ClinicalTrials.gov registry entry for NCT07287397 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The listed sponsor is Vector Y Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which VTx-002 is the first listed.
NCT07287397 reports 11 study locations spanning 7 distinct geographic areas - top geographies include Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT07287397 about?
NCT07287397 is a clinical study titled "Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS". PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS). T...
What is the current status of trial NCT07287397?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-12-19. Estimated completion is 2027-10-15.
What conditions does trial NCT07287397 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT07287397?
The interventions under investigation include: VTx-002 (GENETIC), Optional Rescue medication - Corticosteroids: Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT07287397?
This trial is sponsored by Vector Y Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07287397 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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