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Vaccine Study for Advanced Colorectal and Small Bowel Cancers

This study is testing a new vaccine approach for advanced colorectal and small bowel adenocarcinomas (cancers that start in glandular cells) that have not responded to standard treatments. It uses two vaccines: Ad5.F35-hGUCY2C-PADRE and Lm-GUCY2C. The goal is to find the safest and most effective dose of the Lm-GUCY2C vaccine when given after the Ad5.F35-hGUCY2C-PADRE vaccine. Researchers will be looking for any dose-limiting toxicities (side effects that are severe enough to limit the dose). You may be eligible if you are 18 or older, have a good performance status (ECOG 0 or 1), and your cancer has progressed on other treatments. This study is currently recruiting 18 participants.

Study design
This is an open-label (you and your doctors will know what treatment you are receiving), non-randomized, single-center Phase 1 study. It will enroll 18 participants to test different doses of the Lm-GUCY2C vaccine.
What's involved
You would receive one intramuscular injection of Ad5.F35-hGUCY2C-PADRE, followed four weeks later by two intravenous infusions of Lm-GUCY2C, four weeks apart. You will also have CT scans for disease assessment at the beginning and end of treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed primarily to evaluate safety for eight weeks after the first Lm-GUCY2C vaccination.

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NCT07417488

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Thomas Jefferson University
~18 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Ad5.F35-hGUCY2C-PADRE vaccineLm-GUCY2C vaccineCT Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Dose Limiting Toxicities (DLT) to determine recommended Phase 2 dose (RPTD) of Lm-GUCY2C vaccine boosts following Ad5.F35-hGUCY2C-PADRE vaccine
Measured over 28 days after first Lm-GUCY2C vaccination
+1 more outcome measured

Conditions

Colorectal Cancer
Small Bowel Adenocarcinoma

Explore related trials

Colorectal CarcinomaSmall Intestinal Adenocarcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Babar Bashir, M.D., M.S. · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who to contact

Babar Bashir, M.D., M.S.
[email protected]
215-503-5097
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

An individual who meets any of the following criteria will be excluded from participation in this study:
Topical, ocular, intra-articular, intranasal, and inhalation corticosteroids (with minimal systemic absorption)
Adrenal replacement steroid dose \< 10 mg daily prednisone
A brief (fewer than three days) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction cause by a contrast allergen) 5. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)). Chest wall infus-a-port catheter may be used for treatment administration and will not be subject to this exclusion. 6. Has any immunodeficiency disease or immunocompromised state (e.g., use of immunosuppressive agents including TNF pathway inhibitors, chemotherapy, PI3 kinase inhibitors or radiation therapy within four weeks of study treatment) 7. Has active or history of autoimmune disease (including inflammatory bowel disease), or is a transplant recipient requiring immunosuppressive treatment 8. Has received a diagnosis of HIV, hepatitis B, or hepatitis C (subjects who are hepatitis C positive may be enrolled if they are confirmed with negative viral load at screening) 9. Other malignancy within last 2 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ (eg, cervix, bladder, breast), or prostate cancer in remission 10. Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are:

What this trial measures

  • Rate of Dose Limiting Toxicities (DLT) to determine recommended Phase 2 dose (RPTD) of Lm-GUCY2C vaccine boosts following Ad5.F35-hGUCY2C-PADRE vaccine28 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 period28 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.