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NCT05081492 · ClinicalTrials.gov registry record · Phase 1
CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer
A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05081492: Active Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, sponsored by City of Hope Medical Center.
NCT05081492 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 9 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081492, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells and break them down.
Primary Outcome
Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities/adverse events will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Conditions Studied
Interventions
- BIOLOGICAL Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 1 |
What the registry record for NCT05081492 still lists
NCT05081492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody is the first listed.
NCT05081492 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05081492 about?
NCT05081492 is a clinical study titled "CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer". This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells an...
What is the current status of trial NCT05081492?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2021-10-18. Estimated completion is 2026-03-30.
What conditions does trial NCT05081492 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8.
What interventions are being tested in trial NCT05081492?
The interventions under investigation include: Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT05081492?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05081492 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05081492's enrollment target sits among peer trials
9 58th of 59 higher than 2 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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