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NCT05234307 · ClinicalTrials.gov registry record · Phase 1
PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Dwight Owen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05234307: Recruiting Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Dwight Owen.
NCT05234307 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by Dwight Owen. The registered enrollment target is 30 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05234307, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by Dwight Owen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Safety will be measured by the occurrence of dose-limited toxicities as well as any other adverse events as defined in Common Terminology Criteria for Adverse Events version 5. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. All patients who have received at least o
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Nivolumab
- DRUG Adenosine A2B Receptor Antagonist PBF-1129
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT05234307 shows while recruiting
NCT05234307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT05234307 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05234307 about?
NCT05234307 is a clinical study titled "PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer". This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and n...
What is the current status of trial NCT05234307?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-11-21. Estimated completion is 2026-12-31.
What conditions does trial NCT05234307 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT05234307?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Nivolumab (BIOLOGICAL), Adenosine A2B Receptor Antagonist PBF-1129 (DRUG).
Who is sponsoring clinical trial NCT05234307?
This trial is sponsored by Dwight Owen, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05234307 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05234307's enrollment target sits among peer trials
30 48th of 81 higher than 30 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung 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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