A Phase I, Single-Center, Dose Escalation Trial of Heterologous Prime-Boost Vaccination With Ad5.F35-hGUCY2C-PADRE and Lm-GUCY2C Vaccines in Adults With Advanced Colorectal and Small Bowel Adenocarcinomas

NCT07417488 Phase 1 RECRUITING

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.

Details

Lead sponsor	Thomas Jefferson University
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2026-04-21
Completion	2028-04

Conditions

• Colorectal Cancer
• Small Bowel Adenocarcinoma

Interventions

• Ad5.F35-hGUCY2C-PADRE vaccine
• Lm-GUCY2C vaccine
• CT Scan

Primary outcomes

• Rate of Dose Limiting Toxicities (DLT) to determine recommended Phase 2 dose (RPTD) of Lm-GUCY2C vaccine boosts following Ad5.F35-hGUCY2C-PADRE vaccine — 28 days after first Lm-GUCY2C vaccination
  Number of Participants who experience a dose-limiting toxicity
• Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period — 28 days after first Lm-GUCY2C vaccination
  Number of participants who experience at least once dose-limiting toxicity during the maximum tolerated dose (MTD) evaluation period.

Countries

United States