Metastatic Breast CancerPhase 1NCT06414733
HER-2 B Cell Peptide Vaccine
A Phase 1 study testing Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51 in people with Metastatic Breast Cancer and HER2-positive Breast Cancer, run by Pravin T.P Kaumaya at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, HER2-positive Breast Cancer, EGFR Overexpression
- What is being tested?
- Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 31 Dec 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or esophageal cancer will be enrolled.
- For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable esophageal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease.
- Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
- Patients must have received or refused first line standard systemic therapy for their metastatic/advanced disease.
- Patients with histologically confirmed esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years.
- Patients with histologically confirmed breast cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years.
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- Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study.
- If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the expansion phase of the study.
- If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study.
- If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status. Any clinically approved assay is acceptable. The test can be done at IUSCCC or other CLIA-certified facility.
- Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible.
- Patients must be ambulatory with ECOG performance status 0, 1, or 2 (appendix II).
- Patients must have adequate organ function as defined by:
- ANC ≥ 1,000/mm³, platelet count > 700,000/mm³.
- Serum bilirubin < 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be < 3 times upper limit of normal.
- Creatinine <1.5 mg/dl or calculated creatinine clearance > 60 ml/min
- Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy. Patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent). Patients must have recovered (grade 1 or less) from any clinically significant toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to grade 2 better.
- Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible if their tumor has some expression of HER-2 based on IHC of 1+ or 2+.
- Patients must be at least 18 years of age.
- Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)).
- Men and women of childbearing potential must agree to practice effective contraception while on this study.
- Patients must obtain a base line Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher).
- Ability to understand and the willingness to sign a written informed consent document. The patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- Patients with a history of measles vaccination or infection. a. Patients with no measles vaccination history are eligible. Note: For patients with a history of measles vaccination or infection, they will be monitored for an hour during the skin test for hypersensitivity.
Who cannot join
- Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO/CAP guidelines; or are under-expressing EGFR based on FISH and IHC.
- Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy.
- Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
- Patients who have evidence of active infection that requires parenteral antibiotic therapy.
- Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection.
- Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.
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- Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible.
- Splenectomized patients.
- Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.
- Note: At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.
- Patients who have developed anaphylactic responses to other vaccines.
- Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial. Our estimates for enrollment on the clinical trial are based on a total sample size of 42 patients, assuming that the study enrolls the full complement of 12 patients in the extension phase, and an additional 15 in each of the three disease-specific subgroups as part of the expansion phase of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianpolis, Indiana, 46202
Xin Bryan, RN, 317-274-5495, zhongx@iu.edu
Pravin Kaumaya, PhD
About this study
Official title: 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 51 Adjuvant in Patients With Advanced Solid Tumors
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, HER2-positive Breast Cancer, EGFR Overexpression, Metastatic Esophageal Carcinoma, HER-2 Positive Esophageal Cancer
- Being tested
- Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51
- Keywords
- Phase I, Breast Cancer, GI Cancer
- Medical subject headings
- Breast Neoplasms, Esophageal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51Biological
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 51 vehicle. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with a Montanide ISA 51, and will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.
| Study group | Role | What they receive |
|---|---|---|
| HER-2 vaccine Breast | Experimental | Not described Receives: Biological: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51 |
| HER-2 vaccine GI | Experimental | Not described Receives: Biological: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Measured: through study completion (i.e. up to 1 year post initial vaccine)
Humoral Immune Response
Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296)
Measured: through completion of 3 vaccine series (i.e. up to day 92 post final vaccine injection)
Overall Response Rate
Measured: through completion of 3 vaccine series (i.e. up to day 71)
Secondary outcomes (2)
immunogenicity
ELISA will be analyzed for immunogenicity at baseline, with every vaccine, 21 days after the final vaccine, 6 months from initial vaccination, and at 1 year from initial vaccination to describe time course of antibody production
Measured: through study completion (i.e. up to 1 year post initial vaccine)
T cell functionality
T cell functionality will be determined using proteomic profiling and immunophenotyping
Measured: through study completion (i.e. up to 1 year post initial vaccine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start17 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pravin T.P Kaumaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pravin T.P Kaumaya, Indiana University
- Investigators
- Pravin Kaumaya, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414733
- Sponsor's protocol ID
- CTO-IUSCCC-09138
- Status last verified
- Aug 2026
- First submitted
- 10 May 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No