HER-2 B Cell Peptide Vaccine

NCT ID: NCT06414733

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2030-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HER-2 vaccine Breast

Group Type: EXPERIMENTAL

Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720

Intervention Type: 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.

HER-2 vaccine GI

Group Type: EXPERIMENTAL

Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled.

2. For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal 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.

3. Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.

4. Progressive disease after at least one line of standard therapy.

5. Patients with pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years. Patients with breast and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years.

6. 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.

1. 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.

2. 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.

3. 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. HER-2 status can be performed by a variety of tests. Either IHC or FISH assay are acceptable if breast tumor tissues (previously frozen) are available. The test can be done at IUSCCC or elsewhere if the patient is from out of town.

7. 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.

8. Patients must be ambulatory with an ECOG performance status 0, 1, or 2 (appendix II).

9. Patients must have adequate organ function as defined by:

1. ANC ≥ 1,000/mm³, platelet count > 700,000/mm³.

2. Serum bilirubin < 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be < 2 times upper limit of normal.

3. Creatinine <1.5 mg/dl or calculated creatinine clearance > 60 ml/min

10. 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 from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2.

1. 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+.

11. Patients must be at least 18 years of age.

12. Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)).

13. Men and women must agree to practice effective contraception while on this study.

14. 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).

15. 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.

Exclusion Criteria

1. 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.

2. Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy

3. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.

4. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.

5. Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection.

6. 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.

7. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible.

8. Splenectomized patients.

9. 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.

10. Patients who have developed anaphylactic responses to other vaccines

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pravin T.P Kaumaya

OTHER

Sponsor Role: lead

Responsible Party

Pravin T.P Kaumaya

Director Brown Center for Immuno-Oncology and Vaccine Immunotherapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pravin Kaumaya, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianpolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Xin Bryan, RN

Role: CONTACT

zhongx@iu.edu

317-274-5495

Facility Contacts

Xin Bryan, RN

Role: primary

zhongx@iu.edu

317-274-5495

Other Identifiers

CTO-IUSCCC-09138

Identifier Type: -

Identifier Source: org_study_id