Is NCT07417488 recruiting in Philadelphia, PA?

Yes, NCT07417488 is currently recruiting participants at its Philadelphia, PA location. This colorectal cancer clinical trial is actively enrolling qualified participants.

How do I join the colorectal cancer clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Colorectal Cancer Clinical Trial in Philadelphia, PA

About This Colorectal Cancer Study in Philadelphia

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.

Sponsor: Thomas Jefferson University

Who Can Participate

Inclusion Criteria

Individuals must meet all of the following inclusion criteria 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 for whom standard therapies are intolerable or considered clinically inappropriate by the Investigator are eligible. If a patient refused available standard therapy or Investigator determined standard therapy was inappropriate, the reason for refusal or Investigator determination should be documented.

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 by the patient, or not considered standard practice per institutional standards.

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 not considered standard practice.

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) of disease upon discussion with principal investigator provided other eligilbity criteria are fulfilled.

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 Department of Health and Human Services.

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. Subjects capable of becoming pregnant include any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and who are not postmenopausal. Also, subjects assigned female sex at birth who are physiologically still able to become pregnant by similar definitions detailed here. 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.

Be willing to comply with all the study procedures. All subjects must be able to comprehend and sign a written informed consent document

Exclusion Criteria

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 allergen)

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.

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)

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 (subjects 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 neurologic disease, peripheral vascular disease, or psychiatric illness)

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, peripheral neuropathy, endocrinopathies stable on therapy, and thromboembolic events stable on anticoagulation with no recurrence for \> 6 months. Other Grade 2 AEs may be permitted upon discussion with the PI if not otherwise specified in the protocol.

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 study agent administration.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT07417488) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Colorectal Cancer Treatment Options in Philadelphia, PA

If you're searching for colorectal cancer treatment options in Philadelphia, PA, this clinical trial (NCT07417488) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced colorectal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all colorectal cancer clinical trials near you to find additional studies recruiting in your area.

Colorectal Cancer Clinical Trial in Philadelphia, PA

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