Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07417488

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

Led by Thomas Jefferson University · Updated on 2026-05-08

18

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

T

Thomas Jefferson University

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed advanced or metastatic colorectal or small bowel adenocarcinoma that progressed after standard therapy or lacks standard therapy
  • Patients with MSS colorectal cancer or small bowel adenocarcinoma must have received fluoropyrimidine, oxaliplatin or irinotecan, and VEGF/VEGF receptor inhibitor unless clinically inappropriate or refused
  • Patients with MSI-H and/or dMMR colorectal cancer or small bowel adenocarcinoma must have received a PD-1 or PD-L1 inhibitor unless clinically inappropriate or refused
  • Expected life expectancy greater than 12 weeks
  • At least one extracranial measurable tumor lesion per RECIST version 1.1 or biochemical evidence of disease
  • Adequate peripheral venous access
  • Adequate hematologic function with ANC ≥ 1500 cells/mL, platelets ≥ 75,000/mL, hemoglobin ≥ 9.0 g/dL without recent growth factor support or transfusion
  • Adequate hepatic function including albumin ≥ 3.0 mg/dL, total bilirubin ≤ 2.0 x ULN (or direct bilirubin ≤ 1.5 x ULN for Gilbert syndrome), AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases, and serum creatinine < 2.0 mg/dL
  • Other blood and urine tests not worse than grade 1 abnormalities per CTCAEv5
  • Use of medically acceptable contraception or abstinence during the study and 28 days after final vaccine dose with a negative pregnancy test for women of childbearing potential
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • History of splenectomy
  • History of listeriosis infection or serious reaction to adenovirus
  • Infection requiring systemic antibiotics within 1 week before study treatment
  • Current use of systemic steroids or immunosuppressive drugs with exceptions for certain low absorption or short-term uses
  • Implanted medical devices posing high risk for colonization that cannot be easily removed
  • Immunodeficiency or immunocompromised state, including recent chemotherapy or radiation within 4 weeks
  • Active or history of autoimmune disease or transplant requiring immunosuppressive therapy
  • Diagnosis of HIV, hepatitis B, or hepatitis C (unless hepatitis C viral load is negative at screening)
  • Other malignancies within the last 2 years except certain treated cancers in remission
  • Known active central nervous system metastases or carcinomatous meningitis unless stable and off steroids
  • Intercurrent illnesses that may limit study compliance
  • Inadequate peripheral venous access
  • Use of illicit drugs interfering with study adherence
  • Pregnant or breastfeeding
  • Unresolved toxicities from prior cancer therapies except certain stable grade 2 adverse events
  • Enrollment in another clinical trial that conflicts with this study
  • No restrictions on prior or concurrent preventative vaccines but require at least one week interval between vaccines and study agent administration

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

B

Babar Bashir, M.D., M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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