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NCT06218303 · ClinicalTrials.gov registry record · Phase 1
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
A Phase 1 study of Ductal Carcinoma In Situ, sponsored by Finn, Olivera, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06218303: Recruiting Phase 1 study of Ductal Carcinoma In Situ, sponsored by Finn, Olivera, PhD.
NCT06218303 is a Phase 1 study of Ductal Carcinoma In Situ that is actively recruiting participants, run by Finn, Olivera, PhD. The registered enrollment target is 50 participants, below the 254-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06218303, a Phase 1 study of Ductal Carcinoma In Situ, is actively recruiting participants, sponsored by Finn, Olivera, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.
Primary Outcome
Percentage of patients with a 2-fold or greater increase in serum anti-MUC1 IgG from screening date. Serum IgG is measured using enzyme-linked immunosorbent assay (ELISA).
Conditions Studied
Interventions
- BIOLOGICAL MUC1 Peptide Vaccine
- DRUG Hiltonol®
- DRUG Aromatase Inhibitor
- DRUG Selective estrogen receptor modulator (SERM)
Study Locations (1)
Pennsylvania
- UPMC Magee Womens Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 1 |
What NCT06218303 shows while recruiting
NCT06218303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 254-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Ductal Carcinoma In Situ appearing as the primary indexed condition, and to 4 interventions - of which MUC1 Peptide Vaccine is the first listed.
NCT06218303 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06218303 about?
NCT06218303 is a clinical study titled "Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ". Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuv...
What is the current status of trial NCT06218303?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-02-07. Estimated completion is 2029-03-31.
What conditions does trial NCT06218303 study?
This clinical trial studies the following conditions: Ductal Carcinoma In Situ.
What interventions are being tested in trial NCT06218303?
The interventions under investigation include: MUC1 Peptide Vaccine (BIOLOGICAL), Hiltonol® (DRUG), Aromatase Inhibitor (DRUG), Selective estrogen receptor modulator (SERM) (DRUG).
Who is sponsoring clinical trial NCT06218303?
This trial is sponsored by Finn, Olivera, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06218303 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06218303's enrollment target sits among peer trials
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