A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma

NCT04111172 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 19P.785JT 14133
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. 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.

Conditions

Pancreatic Ductal Adenocarcinoma; Colorectal Adenocarcinoma; Gastric Adenocarcinoma; Clinical Stage II Gastric Cancer AJCC v8; Clinical Stage IIA Gastric Cancer AJCC v8; Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8; Clinical Stage IIB Gastric Cancer AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Malignant Solid Neoplasm; Pathologic Stage II Gastric Cancer AJCC v8; Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Gastric Cancer AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Stage I Pancreatic Cancer AJCC v8; Stage IA Pancreatic Cancer AJCC v8; Stage IB Pancreatic Cancer AJCC v8; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Malignant Digestive System Neoplasm; Small Intestinal Adenocarcinoma; Stage III Small Intestinal Adenocarcinoma AJCC v8; Stage IIIA Small Intestinal Adenocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  AEs classified by System Organ Class, preferred term, severity, and relationship to study treatment, and graded in accordance with the document entitled "Common Terminology Criteria for Adverse Events" (CTCAE), National Cancer Institute version 5 issued by the United States Department of Health and Human Services. Injection-site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site. Clinically-significant changes in safety laboratory tests. The percentage of subjects with AEs and DLTs will be summarized along with corresponding 95% confidence intervals for each treatment arm and overall.

  13 weeks

• Antigen-specific T-cell response to guanylyl cyclase C (GCC)

  Will be measured by enzyme-linked immunosorbent spot (ELISpot) assay. the immune parameters will be summarized via percentages of responders and mean/median values, along with corresponding 95% confidence intervals, by treatment arm and measurement time. Antibody and T-cell data will be summarized by positive response rates (each subject recorded as yes/no) and exact 2-sided 95% confidence intervals. For this study, a statistically significant increase in GCC-specific T-cell response at Weeks 5, 9, or 13 compared with baseline will be considered a response at that time. Significance of the change from baseline will be assessed using the modified distribution-free resampling (DFR) method. Will estimate response rates across disease types.

  13 weeks

Study Arms (3)

Arm A (low dose)

EXPERIMENTAL

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.

Biological: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE

Arm B (medium dose)

EXPERIMENTAL

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.

Biological: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE

Arm C (high dose)

EXPERIMENTAL

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.

Biological: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE

Interventions

Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE BIOLOGICAL

Given as intramuscular injection

Also known as: Ad5.F35-hGCC-PADRE, Ad5/F35-hGCC-PADRE, Adenovirus 5/F35-HGCC-PADRE

Arm A (low dose); Arm B (medium dose); Arm C (high dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Babar Bashir, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 1, 2019
• Study Start: November 10, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)