GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07417488
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ad5.F35-hGUCY2C-PADRE vaccine — BIOLOGICAL
    Ad5.F35-hGUCY2C-PADRE vaccine administered as a single intramuscular injection at a dose of 5 × 10¹² viral particles as the priming vaccination in a heterologous prime-boost vaccination regimen.
  • Lm-GUCY2C vaccine — BIOLOGICAL
    Lm-GUCY2C vaccine administered as an intravenous infusion at dose levels 1 x 10⁸, 3 x 10⁸, 1 x 10⁹, and 3 x 10⁹ colony-forming units (CFU) as booster vaccinations given twice approximately four weeks apart following Ad5.F35-hGUCY2C-PADRE priming.
  • CT Scan — DIAGNOSTIC_TEST
    Spiral CT of thorax, abdomen, and pelvis (and other imaging studies as clinically indicated) for disease assessment at Screening and EOT. If a subject cannot have a CT scan (e.g., allergy to contrast dye), MRI results are acceptable.

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Dose Level -1: Lm-GUCY2C 1 x 10⁸
    Participants receive Ad5.F35-hGUCY2C-PADRE vaccine, administered as a single intramuscular (IM) injection (5 × 10¹² viral particles), followed by Lm-GUCY2C vaccine, administered intravenously at a dose of 1 × 10⁸ colony-forming units (CFU) on two occasions approximately four weeks apart.
  • Experimental: Arm 2 Dose Level 1: Lm-GUCY2C 3 x 10⁸
    Participants receive Ad5.F35-hGUCY2C-PADRE vaccine, administered as a single intramuscular (IM) injection (5 × 10¹² viral particles), followed by Lm-GUCY2C vaccine, administered intravenously at a dose of 3 × 10⁸ colony-forming units (CFU) on two occasions approximately four weeks apart.
  • Experimental: Arm 3 Dose Level 2: Lm-GUCY2C 1 x 10⁹
    Participants receive Ad5.F35-hGUCY2C-PADRE vaccine, administered as a single intramuscular (IM) injection (5 × 10¹² viral particles), followed by Lm-GUCY2C vaccine, administered intravenously at a dose of 1 × 10⁹ colony-forming units (CFU) on two occasions approximately four weeks apart.
  • Experimental: Arm 4 Dose Level 3: Lm-GUCY2C 3 x 10⁹
    Participants receive Ad5.F35-hGUCY2C-PADRE vaccine, administered as a single intramuscular (IM) injection (5 × 10¹² viral particles), followed by Lm-GUCY2C vaccine, administered intravenously at a dose of 3 × 10⁹ colony-forming units (CFU) on two occasions approximately four weeks apart.

Primary Outcome Measure

Rate of Dose Limiting Toxicities (DLT) to determine recommended Phase 2 dose (RPTD) of Lm-GUCY2C vaccine boosts following Ad5.F35-hGUCY2C-PADRE vaccine [ Time Frame: 28 days after first Lm-GUCY2C vaccination ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Babar Bashir, MD
[email protected]
2159558874

Find similar trials in Philadelphia, PA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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