Trials / Recruiting
RecruitingNCT06414733
HER-2 B Cell Peptide Vaccine
Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Pravin T.P Kaumaya · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Metastatic Breast Cancer
- Metastatic Gastrointestinal Carcinoma
- HER2-positive Breast Cancer
- HER2-positive Gastric Cancer
- EGFR Overexpression
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 | 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. |
Timeline
- Start date
- 2025-01-17
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
- First posted
- 2024-05-16
- Last updated
- 2025-08-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06414733. Inclusion in this directory is not an endorsement.