GUCY2C Vaccine for Colorectal and Small Bowel Cancer

Overseen By Babar Bashir, M.D., M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Thomas Jefferson University

Must not be taking: Systemic steroids, Immunosuppressive drugs

Disqualifiers: Splenectomy, Listeriosis, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have at least one tumor outside the brain that can be measured by scans.

I am 18 years old or older.

I have veins suitable for IV access.

Exclusion Criteria

I have been diagnosed with HIV, hepatitis B, or hepatitis C.

Has insufficient peripheral venous access to permit completion of the study phlebotomy regimen or infusion of study vaccine

I can get vaccines like flu or COVID-19 if I wait at least one week before the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ad5.F35-hGUCY2C-PADRE vaccine intramuscularly followed by two administrations of Lm-GUCY2C vaccine intravenously, four weeks apart

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations every 3 months until disease progression or new therapy

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• GUCY2C Prime-Boost Vaccination

How Is the Trial Designed?

Group I: Arm 4 Dose Level 3: Lm-GUCY2C 3 x 10⁹ Experimental Treatment 3 Interventions

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.

Group II: Arm 3 Dose Level 2: Lm-GUCY2C 1 x 10⁹ Experimental Treatment 3 Interventions

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.

Group III: Arm 2 Dose Level 1: Lm-GUCY2C 3 x 10⁸ Experimental Treatment 3 Interventions

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.

Group IV: Arm 1 Dose Level -1: Lm-GUCY2C 1 x 10⁸ Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+