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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 is a Phase 1 study that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 18 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07417488
The ClinicalTrials.gov registry entry for NCT07417488 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which CT Scan is the first listed.
NCT07417488 reports 0 study locations.
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.
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