Vaccine for Gastrointestinal Cancer

Overseen By Babar Bashir

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Must not be taking: Systemic steroids, Immunosuppressive drugs

Disqualifiers: Brain metastasis, Autoimmune disease, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine designed to train the immune system to identify and destroy tumor cells in patients with certain types of gastrointestinal cancer. The trial evaluates the vaccine's effectiveness and potential side effects. Participants will receive one of three doses to assess its efficacy. This trial suits individuals previously treated for pancreatic, colorectal, gastric, or esophageal cancer who currently show no signs of the disease but face a high risk of recurrence. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic steroids or immunosuppressive drugs during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Ad5.F35-hGCC-PADRE vaccine underwent safety testing in earlier studies. In one study involving patients with colorectal cancer, the vaccine proved to be safe. No long-term harmful effects were reported. Some patients experienced mild side effects, such as brief pain or swelling at the injection site, body aches, and chills. These findings suggest that the vaccine is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Ad5.F35-hGCC-PADRE vaccine for gastrointestinal cancer because it represents a novel approach compared to traditional treatments like chemotherapy and radiation. Unlike these standard treatments, which broadly attack cancer cells, this vaccine specifically targets the human guanylyl cyclase C (hGCC) protein, which is often found in gastrointestinal tumors. By focusing on this specific protein, the vaccine aims to boost the body's immune response directly against cancer cells, potentially offering a more precise and less toxic treatment option. Additionally, the vaccine is administered intramuscularly, which might be less invasive and more convenient than some existing therapies.

What evidence suggests that the Ad5.F35-hGCC-PADRE vaccine might be an effective treatment for gastrointestinal cancer?

Research has shown that the Ad5.F35-hGCC-PADRE vaccine might help the immune system recognize and destroy cancer cells in gastrointestinal adenocarcinoma. Early studies found that this vaccine is safe, with only mild side effects such as brief pain or swelling at the injection site. In this trial, participants will receive different doses of the vaccine—low, medium, or high—to evaluate its effectiveness and safety. The treatment aims to strengthen the body’s natural defenses to fight cancer and prevent its recurrence. This method has shown promise in earlier research for colorectal cancer. Overall, the vaccine aims to help the immune system keep cancer under control. ^{1 2 3 4 6}

Who Is on the Research Team?

Babar Bashir, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults with gastrointestinal adenocarcinoma who've had treatment aiming to cure and currently show no signs of the disease. They must be in good physical condition, not have severe kidney issues, use effective contraception if childbearing potential, and not have other serious health problems or a history of certain diseases.

Inclusion Criteria

You have had certain types of tumors and have been treated with the goal of curing the cancer. After treatment, there is no sign of the disease, with some exceptions for small remaining tumors or certain test results. Treatment must have finished between four and 25 weeks before starting the study.

Have an anticipated life expectancy of greater than 12 weeks

For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormonal implants) or abstinence must be used throughout the study period and for 28 days after their final vaccine administration (a barrier method of contraception must be employed by all subjects [male and female], regardless of other methods unless abstinent). A negative serum or urine pregnancy test is required as part of screening. Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/ml

Exclusion Criteria

You have received immunotherapy or experimental medications after finishing standard treatment.

You still have signs of the disease even after having surgery to remove it.

You have cancer that has spread to your brain or central nervous system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ad5.F35-hGCC-PADRE vaccine intramuscularly on day 1 of weeks 1, 5, and 9 at varying doses depending on the arm

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

1 visit (in-person)

Long-term Follow-up

Participants are followed up every 3 months for at least 24 months to evaluate disease-free survival and overall survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Ad5.F35-hGCC-PADRE

Trial Overview The trial is testing a vaccine called Ad5.F35-hGCC-PADRE to see how well it works and what side effects it has on patients with gastrointestinal adenocarcinoma. The goal is for the vaccine to teach the immune system to recognize and kill cancer cells.

How Is the Trial Designed?

Group I: Arm C (high dose) Experimental Treatment 1 Intervention

Patients receive high dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (medium dose) Experimental Treatment 1 Intervention

Patients receive medium dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.

Group III: Arm A (low dose) Experimental Treatment 1 Intervention

Patients receive low dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

Dendritic cell (DC) vaccines, derived from a patient's own blood, have shown promise in safely initiating specific T cell responses against tumors, with Phase I/II trials indicating minimal side effects.

These vaccines can potentially target a wide range of human cancers, including gastrointestinal cancers, even in cases where specific tumor antigens are not well-defined, making them a versatile option for cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic cell-based cancer immunotherapy: potential for treatment of colorectal cancer? Chen, W., Rains, N., Young, D., et al.[2019]

The OTSGC-A24 cancer vaccine was well tolerated in a phase I/Ib trial with 24 patients suffering from advanced gastric cancer, showing no dose-limiting toxicities and manageable side effects like decreased appetite and injection site reactions.

Significant immune responses were observed, with 90% of patients showing positive cytotoxic T lymphocyte (CTL) responses at 12 weeks, leading to a recommended dosing schedule of 1 mg every 2 weeks for further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. Sundar, R., Rha, SY., Yamaue, H., et al.[2022]

The dendritic cell vaccine, made from patients' own cells and tumor RNA, was well tolerated in 15 patients with advanced colorectal cancer, with no major adverse effects reported during the treatment.

While no dramatic clinical responses were observed yet, 7 out of 13 patients showed a decrease in carcinoembryonic antigen levels, indicating a potential anticancer effect that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a dendritic cell (DC)-based vaccine for patients with advanced colorectal cancer. Rains, N., Cannan, RJ., Chen, W., et al.[2020]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-05481

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of ... Ad5. F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.

2. withpower.com withpower.com/trial/phase-3-stomach-neoplasms-10-2020-52da3

Vaccine for Gastrointestinal Cancer · Info for Participants F35-hGCC-PADRE, was tested in a phase I study for colorectal cancer and was found to be safe, with no long-term adverse effects reported.

3. trialx.com trialx.com/clinical-trials/listings/249984/a-vaccine-ad5f35-hgcc-padre-for-the-treatment-of-gastrointestinal-adenocarcinoma/

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of ... Ad5. F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4652457/

A Phase I study of AD5-GUCY2C-PADRE in stage I and II ... The vaccine was well tolerated, producing only mild adverse events (AEs). Short-lived injection site pain/swelling, body aches and chills were ...

5. fightcolorectalcancer.org fightcolorectalcancer.org/clinical-trial/nct04111172/

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of ... A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma ... April 2019: phase I clinical trial reported that the cancer vaccine Ad5 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443303/

Chimeric Ad5.F35 vector evades anti-adenovirus serotype ... This chimeric vector resisted neutralization in Ad5-immunized mice and by sera collected from patients with colorectal cancer naturally exposed to Ad5.