HER-2 B Cell Peptide Vaccine

NCT06414733 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CTO-IUSCCC-09138
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Phase I; Breast Cancer; GI Cancer

Outcome Measures

Primary Outcomes (3)

• Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 4.0

  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)

  through completion of 3 vaccine series (i.e. up to day 92 post final vaccine injection)

• Overall Response Rate

  through completion of 3 vaccine series (i.e. up to day 71)

Secondary Outcomes (2)

• immunogenicity

  through study completion (i.e. up to 1 year post initial vaccine)

• T cell functionality

  through study completion (i.e. up to 1 year post initial vaccine)

Study Arms (2)

HER-2 vaccine Breast

EXPERIMENTAL

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

HER-2 vaccine GI

EXPERIMENTAL

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

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.

HER-2 vaccine Breast; HER-2 vaccine GI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• Progressive disease after at least one line of standard therapy.
• 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.
• 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. 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.
• 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 an 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 \< 2 times upper limit of normal.
• Creatinine \<1.5 mg/dl or calculated creatinine clearance \> 60 ml/min

You may not qualify if:

• 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 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.
• 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.
• 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

Sponsors & Collaborators

• Pravin T.P Kaumaya: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianpolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms

Interventions

mannide monooleate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Pravin Kaumaya, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Bryan, RN

CONTACT

317-274-5495; zhongx@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Brown Center for Immuno-Oncology and Vaccine Immunotherapy

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)