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NCT05078866 · ClinicalTrials.gov registry record · Phase 1
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients
A Phase 1 study of Colorectal Carcinoma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 4
- Study locations
NCT05078866 is a Phase 1 study of Colorectal Carcinoma and Lynch Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05078866, a Phase 1 study of Colorectal Carcinoma and Lynch Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 have an effect on the development of polyps or tumors in the colon.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- PROCEDURE Endoscopic Biopsy
- BIOLOGICAL Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP
- BIOLOGICAL MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP
Study Locations (4)
California
- City of Hope Comprehensive Cancer Center - Duarte
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Texas
- M D Anderson Cancer Center - Houston
Other
- University of Puerto Rico - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-11-10 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05078866
The ClinicalTrials.gov registry entry for NCT05078866 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05078866 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05078866 about?
NCT05078866 is a clinical study titled "Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients". This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of...
What is the current status of trial NCT05078866?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2022-11-10. Estimated completion is 2026-09-30.
What conditions does trial NCT05078866 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, Lynch Syndrome.
What interventions are being tested in trial NCT05078866?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Endoscopic Biopsy (PROCEDURE), Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP (BIOLOGICAL), MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP (BIOLOGICAL).
Who is sponsoring clinical trial NCT05078866?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05078866 being conducted?
This trial has 4 study locations across California, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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