Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Finn, Olivera, PhD
Study ID
NCT06218303
Phase
PHASE1
Status
Recruiting
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Conditions

  • Ductal Carcinoma in Situ

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MUC1 Peptide Vaccine — BIOLOGICAL
    MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
  • Hiltonol® — DRUG
    A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
  • Aromatase Inhibitor — DRUG
    A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
  • Selective estrogen receptor modulator (SERM) — DRUG
    A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.

Study Details

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.

Key Dates

Start date
Feb 7, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Mar 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM
    MUC1 peptide vaccine with poly-ICLC adjuvant Hiltonol administered subcutaneously (SQ) Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily or Selective estrogen receptor modulator (SERM) - Tamoxifen 20 mg by mouth daily (pre-menopausal)
  • Active Comparator: Aromatase Inhibitor or SERM
    Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily (post-menopausal) or Selective estrogen receptor modulator (SERM) - Tamoxifen 20 mg by mouth daily (pre-menopausal)

Primary Outcome Measure

Immunogenicity (of MUC1 vaccine) [ Time Frame: At Screening, Week 2, Week 4, Week 6, Week 10, Week 12, Week 16, Week 20, Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Magee Womens HospitalPittsburghPennsylvania15213
Kelsey Mitch, RN, BSN
[email protected]
412-623-6793
Lucia Borrasso, BS
[email protected]
412-641-3304
Emilia Diego, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Magee Womens Hospital· Pittsburgh, PA

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