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NCT07417488 · ClinicalTrials.gov registry record · Phase 1
GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas
A Phase 1 study, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07417488: Recruiting Phase 1 study, sponsored by Thomas Jefferson University.
NCT07417488 is a Phase 1 study that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07417488, a Phase 1 study, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized, single-center, dose-escalation Phase 1 trial using a heterologous prime-boost strategy of vaccination with Ad5.F35-hGUCY2C-PADRE and recombinant Listeria monocytogenes (Lm-GUCY2C) vaccines in patients with advanced solid tumors including colorectal cancer, and small bowel adenocarcarcinomas who have progressed on available standard therapies. The study treatment will begin with Ad5.F35-hGUCY2C-PADRE vaccine administered intramuscularly (IM) once at the recommended Phase 2 dose (RPTD) dose, followed four weeks later by two administrations of Lm-GUCY2C intravenously (IV) at one of three escalating dose levels, four weeks apart. Treatment-related toxicity and development of immune responses will be evaluated every four weeks through week 8 after initial Lm-GUCY2C vaccination. Primary endpoints will include maximum tolerated dose (MTD) and safety and tolerability as measured by treatment emergent adverse events (TEAEs) and clinically significant changes in safety laboratory tests in the dose limiting toxicity (DLT) evaluation period defined as 4 weeks after the initial Lm-GUCY2C vaccination.
Primary Outcome
Number of Participants who experience a dose-limiting toxicity
Interventions
- DIAGNOSTIC_TEST CT Scan
- BIOLOGICAL Ad5.F35-hGUCY2C-PADRE vaccine
- BIOLOGICAL Lm-GUCY2C vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-04-21 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
What NCT07417488 shows while recruiting
NCT07417488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which CT Scan is the first listed.
NCT07417488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07417488 about?
NCT07417488 is a clinical study titled "GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas". This is an open-label, non-randomized, single-center, dose-escalation Phase 1 trial using a heterologous prime-boost strategy of vaccination with Ad5.F35-hGUCY2C-PADRE and recombinant Listeria monocytogenes (Lm-GUCY2C) vaccines in patients with advanced solid tumors including colorectal cancer, and ...
What is the current status of trial NCT07417488?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-04-21. Estimated completion is 2028-04.
What interventions are being tested in trial NCT07417488?
The interventions under investigation include: CT Scan (DIAGNOSTIC_TEST), Ad5.F35-hGUCY2C-PADRE vaccine (BIOLOGICAL), Lm-GUCY2C vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07417488?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07417488's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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