HER-2 B Cell Peptide Vaccine

Part of paid clinical trials in Indianpolis, Indiana.

Sponsor
Pravin T.P Kaumaya
Study ID
NCT06414733
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 — BIOLOGICAL
    Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified in ISA 720 vehicle. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with a Montanide ISA 720, and will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.

Study Details

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.

Key Dates

Start date
Jan 17, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HER-2 vaccine Breast
  • Experimental: HER-2 vaccine GI

Primary Outcome Measure

Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 4.0 [ Time Frame: through study completion (i.e. up to 1 year post initial vaccine) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin & Bren Simon Comprehensive Cancer CenterIndianpolisIndiana46202
Xin Bryan, RN
[email protected]
317-274-5495
Pravin Kaumaya, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianpolis, IN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Indiana University Melvin & Bren Simon Comprehensive Cancer Center· Indianpolis, IN

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