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NCT05393713 · ClinicalTrials.gov registry record · Phase 1
Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT05393713: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT05393713 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05393713, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Interventions
- PROCEDURE Punch Biopsy
- BIOLOGICAL Anti-PD-L1 Monoclonal Antibody IMC-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-10-17 |
| Est. Completion | 2025-02-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05393713
The ClinicalTrials.gov registry entry for NCT05393713 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Punch Biopsy is the first listed.
NCT05393713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05393713 about?
NCT05393713 is a clinical study titled "Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study". This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than...
What is the current status of trial NCT05393713?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2022-10-17. Estimated completion is 2025-02-16.
What interventions are being tested in trial NCT05393713?
The interventions under investigation include: Punch Biopsy (PROCEDURE), Anti-PD-L1 Monoclonal Antibody IMC-001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05393713?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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