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 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 intr

Trial Details

NCT ID
NCT07417488
Phase
PHASE1
Sponsor
Thomas Jefferson University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Ad5.F35-hGUCY2C-PADRE vaccine
  • Lm-GUCY2C vaccine
  • CT Scan
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
  • Males or females aged ≥ 18 years
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically diagnosed, locally advanced or metastatic adenocarcinomas of colorectum or small bowel that have progressed after s…

For full eligibility, visit ClinicalTrials.gov.

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