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NCT04111172 · ClinicalTrials.gov registry record · Phase 2
A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
A Phase 2 study of Malignant Solid Neoplasm and Pancreatic Ductal Adenocarcinoma, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04111172: Active Phase 2 study of Malignant Solid Neoplasm and Pancreatic Ductal Adenocarcinoma, sponsored by Thomas Jefferson University.
NCT04111172 is a Phase 2 study of Malignant Solid Neoplasm and Pancreatic Ductal Adenocarcinoma that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 48 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04111172, a Phase 2 study of Malignant Solid Neoplasm and Pancreatic Ductal Adenocarcinoma, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 safet
Conditions Studied
Interventions
- BIOLOGICAL Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What the registry record for NCT04111172 still lists
NCT04111172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE is the first listed.
NCT04111172 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04111172 about?
NCT04111172 is a clinical study titled "A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma". 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 c...
What is the current status of trial NCT04111172?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-11-10. Estimated completion is 2027-03-01.
What conditions does trial NCT04111172 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Clinical Stage III Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT04111172?
The interventions under investigation include: Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE (BIOLOGICAL).
Who is sponsoring clinical trial NCT04111172?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04111172 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04111172's enrollment target sits among peer trials
48 131st of 176 higher than 46 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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