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NCT04116320 · ClinicalTrials.gov registry record · Phase 1
Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors
A Phase 1 study, sponsored by Craig L Slingluff, Jr.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04116320: Clinical Trial Phase 1 study, sponsored by Craig L Slingluff, Jr.
NCT04116320 is a Phase 1 study that was terminated before completion, run by Craig L Slingluff, Jr. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04116320, a Phase 1 study, was terminated before completion, sponsored by Craig L Slingluff, Jr.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with intratumoral poly-ICLC.
Primary Outcome
Incidence and severity of adverse events and incidence of dose-limiting toxicities (DLTs).
Interventions
- DRUG Poly ICLC
- DEVICE Echopulse
- DRUG Standard of Care PD-1 Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
Why NCT04116320 stopped before completion
NCT04116320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Poly ICLC is the first listed.
NCT04116320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04116320 about?
NCT04116320 is a clinical study titled "Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors". This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease...
What is the current status of trial NCT04116320?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-11-21. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT04116320?
The interventions under investigation include: Poly ICLC (DRUG), Echopulse (DEVICE), Standard of Care PD-1 Therapy (DRUG).
Who is sponsoring clinical trial NCT04116320?
This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04116320's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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