Clinical trial · Interventional
A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
A Phase 2A/2B, Dose-Finding and Expansion Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Why stopped (as posted): Protocol is with FDA review, waiting for funding to be released
Summary
Brief summary (as posted)
This is an open-label, dose-finding, Phase 2A/2B study of Ad5.F35-hGCC-PADRE as a vaccine for gastrointestinal (GI) malignancies (pancreatic, colorectal, esophageal, gastric, and small bowel adenocarcinomas) who have received surgical resection and standard adjuvant therapy. In Phase 2A, patients will be given multiple administrations of Ad5.F35-hGCC-PADRE intramuscularly at 1 of 3 dose levels. Treatment-related toxicity and development of immune responses to GCC will be evaluated at Weeks 5, 9, and 13 after the initial vaccination (Week 1). Primary safety endpoints will examine adverse events (AEs), injection-site reactions and clinically-significant changes in safety laboratory tests. Primary efficacy endpoints include the development of GCC-specific T-cell responses at different dose levels (1011, 1012, and 5x1012 virus particles or vp). In Phase 2B Dose Expansion cohort, a group of 20 colon cancer patients who are ctDNA+ by CLIA-certified standard of care assays will receive a single administration of Ad5.F35-hGCC-PADRE vaccine intramuscularly at prespecified dose of 1012 vp. Phase 2b is NOT randomized. Primary safety endpoints will examine AEs, injection-site reactions and clinically significant changes in safety laboratory tests. The primary efficacy endpoints include GCC-specific T-cell responses at 1012 vp in ctDNA+ patients. Additional exploratory endpoint will determine elimination of minimal residual disease (MRD) by ctDNA clearance.
Conditions
Conditions (38)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage IIA Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A (low dose)
- description
- 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.
- interventionNames
- Biological: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE
- type
- EXPERIMENTAL
- label
- Arm B (medium dose)
- description
- 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.
- interventionNames
- Biological: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE
- type
- EXPERIMENTAL
- label
- Arm C (high dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Subjects with tumors specified below, who are at high risk of relapse, have been treated with curative intent, and have no evidence of disease (NED) following front-line therapy with surgery, radiation therapy, and/or chemotherapy. NED includes, where applicable, surgical (macroscopic tumor margin, at the time of surgery), and radiological evidence of disease. Residual lesions identified by microscopic/frozen margins and biochemical markers are permitted. Therapy must have been completed no fewer than four weeks, and no later than 25 weeks, before the first dose of Ad5.F35-hGCC-PADRE
* For tumor-specific criteria, please refer to the information below:
\* Pancreatic ductal adenocarcinoma
\*\* Stage I, II, III
* Neuroendocrine tumors of the pancreas are not permitted
\* Colorectal adenocarcinoma
* Stage III; stage IV following metastasectomy
\* Gastric adenocarcinoma
* Stage IIA, IIB, III
* Gastrointestinal stromal tumors of the stomach are not permitted
\* Esophageal adenocarcinoma
\*\* Stage IIB, III
* Esophageal squamous cell carcinomas are not permitted
* Have an anticipated life expectancy of greater than 12 weeks
* Absolute neutrophil count (ANC) \>= 1000 cells/mL
* Platelets \>= 75,000 /mL
* Hemoglobin \>= 9.0 g/dL
* 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 Common Terminology Criteria for Adverse Events (CTCAE), National Cancer Institute (NCI) version 5 issued by the United States (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. 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
* 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:
* Have a known history or evidence of residual disease after definitive surgery
* Have a known metastasis in the brain or central nervous system
* Prior receipt of immunotherapy or experimental medications after completion of standard adjuvant therapy
* Have a history of splenectomy
* Have a history of distal pancreatectomy
* Concurrent use of systemic steroids or immunosuppressive drugs (use of topical or inhaled steroids will be allowed)
* Have any immunodeficiency disease or immunocompromised state (e.g., use of immunosuppressive agents, chemotherapy or radiation therapy within four weeks of study treatment)
* Have active autoimmune disease or history of autoimmune disease or a transplant recipient requiring systemic steroids or other immunosuppressive treatment
* Have received a diagnosis of human immunodeficiency virus (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 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early-stage (stage A or B1) prostate cancer
* Have a history of inflammatory bowel disease
* Have a history of serious reaction to adenovirus
* Have 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)
* Have insufficient peripheral venous access to permit completion of the study phlebotomy regimen
* Consumes greater than three glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\]) per day and cannot refrain from alcohol for the duration of the trial
* Has a history of use of illicit drugs (e.g., opioids, cocaine, amphetamines, hallucinogens, etc.) that could potentially interfere with adherence to study procedures or requirements
* Be a woman who is pregnant or breastfeeding
* Have an unhealed surgical wound
* Have had major surgery or significant traumatic injury occurring within 28 days before treatment or anticipated surgery or procedure requiring general anesthesia during the study participation (including four weeks after last dose of vaccine)References
Publications (0)
Data not yet available