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NCT03384316 · ClinicalTrials.gov registry record · Phase 1
Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03384316 is a Phase 1 study of Breast Cancer and Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03384316, a Phase 1 study of Breast Cancer and Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune system to target and kill cancer cells. The vaccines target 3 proteins found in many types of cancer. Researchers think targeting all 3 proteins in unison will have the best results. Objective: To test the safety of combining ETBX-011, ETBX-061, and ETBX-051 and their effects on the immune system. Eligibility: People ages 18 and older with advanced cancer that has not responded to standard therapies Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Scan: They will lie in a machine that takes pictures of the body. Participants will receive the 3 vaccines through 3 shots under the skin every 3 weeks for 3 doses, then every 8 weeks for up to 1 year. They will have blood and urine tests at each vaccine visit. They will have scans and other measurements of their tumor after 9 weeks and then at their vaccine visits every 8 weeks. Participants will keep a diary of symptoms at the injection site. Participants will have a visit 90 days after their final treatment. This will include a physical exam and blood and urine tests. If they have any ongoing side effects, they will be followed until these end or are not changing. After this visit, they will be called every 3 months for the first year, every 6 months for the next 2 years, then every 12 months for another 2 years to see how they are doing. Participants will have the option to enroll in a long-term follow-up study. ...
Conditions Studied
Interventions
- BIOLOGICAL ETBX-051; adenoviral brachyury vaccine
- BIOLOGICAL ETBX-061; adenoviral Mucin-1 (MUC1) vaccine
- BIOLOGICAL ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03384316
The ClinicalTrials.gov registry entry for NCT03384316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which ETBX-051; adenoviral brachyury vaccine is the first listed.
NCT03384316 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03384316 about?
NCT03384316 is a clinical study titled "Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer". Background: ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune system to target and kill cancer cells. The vaccines target 3 proteins found in many types of cancer. Researchers think targeting all 3 proteins in unison will have the best results. Objective: To ...
What is the current status of trial NCT03384316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-01-31. Estimated completion is 2020-08-24.
What conditions does trial NCT03384316 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Neoplasms, Colon Cancer.
What interventions are being tested in trial NCT03384316?
The interventions under investigation include: ETBX-051; adenoviral brachyury vaccine (BIOLOGICAL), ETBX-061; adenoviral Mucin-1 (MUC1) vaccine (BIOLOGICAL), ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03384316?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03384316 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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