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NCT03328026 · ClinicalTrials.gov registry record · Phase 1
Combination Study of SV-BR-1-GM With Retifanlimab
A Phase 1 study, sponsored by BriaCell Therapeutics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03328026 is a Phase 1 study that has completed, run by BriaCell Therapeutics Corporation. The registered enrollment target is 36 participants.
The verdict
NCT03328026, a Phase 1 study, has completed, sponsored by BriaCell Therapeutics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy. Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.
Interventions
- BIOLOGICAL SV-BR-1-GM
- DRUG retifanlimab
- DRUG Low dose cyclophosphamide
- DRUG Interferon Inoculation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2026-03-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03328026
The ClinicalTrials.gov registry entry for NCT03328026 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BriaCell Therapeutics Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which SV-BR-1-GM is the first listed.
NCT03328026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03328026 about?
NCT03328026 is a clinical study titled "Combination Study of SV-BR-1-GM With Retifanlimab". This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy. Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be a...
What is the current status of trial NCT03328026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-03-16. Estimated completion is 2026-03-24.
What interventions are being tested in trial NCT03328026?
The interventions under investigation include: SV-BR-1-GM (BIOLOGICAL), retifanlimab (DRUG), Low dose cyclophosphamide (DRUG), Interferon Inoculation (DRUG).
Who is sponsoring clinical trial NCT03328026?
This trial is sponsored by BriaCell Therapeutics Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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