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New treatment option for Colorectal Cancer
Official title GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas
ClinicalTrials.gov ID: NCT07417488
What this study is testing
What is Ad5.F35-hGUCY2C-PADRE vaccine?
Ad5.F35-hGUCY2C-PADRE vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Also referred to as Ad5/F35-hGCC-PADRE, Adenovirus 5/F35-HGCC-PADRE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals must meet all of the following in order to be eligible to participate in the study:
- Males or females aged ≥ 18 years
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically diagnosed, locally advanced or metastatic adenocarcinomas of colorectum or small bowel that have progressed after...
- Patients with MSS CRC or small bowel adenocarcinoma must have received at least 1) a fluoropyrimidine, 2) oxaliplatin or irinotecan, and 3) a...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of splenectomy
- History of infection with listeriosis or has prior serious reaction to adenovirus
- Infection requiring systemic antibiotics within 1 week prior to administration of study intervention
- Concurrent use of systemic steroids or immunosuppressive drugs (including TNF pathway inhibitors) with exceptions including:
- Topical, ocular, intra-articular, intranasal, and inhalation corticosteroids (with minimal systemic absorption)
See the full eligibility criteria
Who can join
- Individuals must meet all of the following in order to be eligible to participate in the study:
- Males or females aged ≥ 18 years
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically diagnosed, locally advanced or metastatic adenocarcinomas of colorectum or small bowel that have progressed after standard of care therapy or for which no standard therapy exists...
- Patients with MSS CRC or small bowel adenocarcinoma must have received at least 1) a fluoropyrimidine, 2) oxaliplatin or irinotecan, and 3) a VEGF/VEGF receptor inhibitor unless deemed clinically inappropriate, refused...
- Patients with MSI-H and/or dMMR CRC or small bowel adenocarcinoma must have received a programmed death-1 or programmed death-ligand 1 (PD-L1) inhibitor unless deemed clinically inappropriate, refused by the patient, or...
- Have an anticipated life expectancy of greater than 12 weeks
- Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exceptions may be made to this inclusion if a patient has biochemical evidence (ctDNA)...
- Adequate venous access by peripheral vein evaluation
- Have adequate hematologic function at screening, as evidenced by:
- ANC ≥ 1500 cells/mL; no growth factor support within 14 days prior to Screening assessment
- Platelets ≥ 75,000 /mL; no transfusion within 14 days prior to Screening assessment
- Hemoglobin ≥ 9.0 g/dL; no transfusion or erythyropoietin support within 14 days prior to Screening assessment.
- Patients must have adequate hepatic function, as evidenced by:
- Albumin ≥ 3.0 mg/dL; no albumin support within 14 days prior to Screening assessment,
- Total bilirubin ≤ 2.0 x upper limit of normal (ULN), except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤ 1.5 x ULN is required)
- Aspartate aminotransferase (AST) AND alanine aminotransferase ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases.
- Serum creatinine \< 2.0 mg/dL
- For other blood and urine tests including blood chemistry, hepatic and renal functions, test results should not be worse than grade 1 levels of abnormalities defined by CTCAE, NCI version 5 (CTCAEv5) issued by the US...
- 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...
- Be willing to comply with all the study procedures. All people must be able to comprehend and sign a written informed consent document
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of splenectomy
- History of infection with listeriosis or has prior serious reaction to adenovirus
- Infection requiring systemic antibiotics within 1 week prior to administration of study intervention
- Concurrent use of systemic steroids or immunosuppressive drugs (including TNF pathway inhibitors) with exceptions including:
- 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...
- people 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...
- 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...
- Has active or history of autoimmune disease (including inflammatory bowel disease), or is a transplant recipient requiring immunosuppressive treatment
- Has received a diagnosis of HIV, hepatitis B, or hepatitis C (people who are hepatitis C positive may be enrolled if they are confirmed with negative viral load at screening)
- 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
- Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are:
- Radiologically stable, ie, without evidence of progression for at least 12 weeks by repeat imaging
- Clinically stable per investigator assessment
- Without requirement of steroid treatment for at least 14 days prior to first dose of study vaccine
- Has an intercurrent illness that is either life-threatening or of clinical importance such that it might limit study compliance (such illnesses include, but are not limited to, ongoing or active infection, metabolic or...
- Has insufficient peripheral venous access to permit completion of the study phlebotomy regimen or infusion of study vaccine
- Concurrent use of illicit drugs (e.g., opioids, cocaine, amphetamines, hallucinogens, etc.) that could potentially interfere with adherence to study procedures or requirements.
- Be pregnant or breastfeeding
- Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less or baseline except for the following Grade 2 AEs that are considered chronic or irreversible: alopecia...
- Are currently enrolled in an ongoing clinical trial or trial that could interfere with the protocol-specified requirements
- There are no restrictions on concurrent or prior use of preventative vaccines for infectious diseases including influenza or COVID-19, however it is required to include at least one week interval between vaccines and...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.