What side effects are associated with this type of intervention?

Common treatments for HER2-expressing breast cancer, such as trastuzumab and pertuzumab, often cause side effects including cardiotoxicity, infusion reactions, and gastrointestinal symptoms like nausea and diarrhea. When combined with chemotherapy agents like taxanes, additional side effects can include alopecia, neuropathy, and myelosuppression, which increases the risk of infections, anemia, and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for HER2-positive breast cancer, which overexpresses the HER2 protein. Key drugs include trastuzumab (Herceptin), a monoclonal antibody that targets the HER2 receptor, and pertuzumab (Perjeta), which also targets HER2 but binds to a different epitope than trastuzumab. Additionally, ado-trastuzumab emtansine (Kadcyla) combines trastuzumab with a chemotherapy agent to deliver targeted cytotoxicity. Lapatinib (Tykerb) is a small molecule tyrosine kinase inhibitor that targets both HER2 and EGFR. These treatments have significantly improved outcomes for patients with HER2-positive breast cancer.

What other types of research exist?

Promising novel alternatives to the TAEK-VAC-HerBy vaccine for breast cancer patients include investigational agents such as regorafenib, cabozantinib, sorafenib, and lenvatinib. Additionally, therapies like bevacizumab combined with chemotherapy (e.g., cisplatin and gemcitabine) have shown promise in other cancer types and may be considered.

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Cancer Vaccine

TAEK-VAC-HerBy Vaccine for Cancer

Phase 1

Waitlist Available

Led By Mary (Nora) L Disis, MD

Research Sponsored by Bavarian Nordic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have normal organ and bone marrow function as defined in the protocol

Patients are required to be on active treatment with HER2 antibodies (trastuzumab, pertuzumab) prior to and during study treatment

Must not have

Known history of, or any evidence of active, non-infectious pneumonitis or primary pulmonary fibrosis.

Clinically significant cardiomyopathy, coronary disease, congestive heart failure (NYHA class III or IV) or reduced as per institutional standards LVEF, poorly controlled hypertension (systolic >180 mm Hg or diastolic >100 mm Hg) or cerebrovascular accident within 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dlt evaluation period is 30 days after the last vaccine dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine called TAEK-VAC-HerBy, given through an injection, in patients with advanced cancer. The vaccine aims to help the immune system recognize and attack cancer cells.

Who is the study for?

Adults with advanced cancers expressing brachyury and/or HER2, such as chordoma, breast, or gastric cancer. Participants must have good heart function and performance status, no severe heart disease or uncontrolled hypertension, no central nervous system metastases unless stable post-treatment, not be immunocompromised or on high-dose steroids recently. Prior cancer treatments should be completed at least 3 weeks before the trial.

What is being tested?

The TAEK-VAC-HerBy vaccine is being tested in two stages: a dose escalation to find the best dose followed by treatment of chordoma patients with the vaccine alone or breast/gastric cancer patients with both the vaccine and HER2 antibodies. The vaccine is given intravenously every three weeks for a total of three doses.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue; allergic reactions; and any specific side effects related to immune response due to vaccination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ and bone marrow functions are normal.

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I am currently being treated with HER2 antibodies like trastuzumab.

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I finished my last cancer treatment at least 3 weeks ago, or 5 half-lives ago for specific drugs.

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My cancer can be measured on a scan.

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I have received less than the maximum allowed dose of doxorubicin or epirubicin.

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My heart pumps blood normally.

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My cancer cannot be removed by surgery and has spread.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung inflammation or scarring not caused by infections.

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I do not have severe heart issues, uncontrolled high blood pressure, or recent strokes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dlt evaluation period is 30 days after the last vaccine dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dlt evaluation period is 30 days after the last vaccine dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and dlt evaluation period is 30 days after the last vaccine dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patients with Dose Limiting Toxicity (DLT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy)Experimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously to patients who are on stable dose of trastuzumab, every three weeks with three administrations in total at the dose defined in stage 1.

Group II: Stage 2: Chordoma Cancer CohortExperimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level defined in stage 1.

Group III: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E9 Inf.U)Experimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E9 Inf.U.

Group IV: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E8 Inf.U)Experimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E8 Inf.U.

Group V: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E7 Inf.U)Experimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E7 Inf.U.

Group VI: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E10 Inf.U)Experimental Treatment1 Intervention

TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E10 Inf.U.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HER2-positive breast cancer, such as trastuzumab and pertuzumab, work by binding to the HER2 receptors on cancer cells, thereby inhibiting their growth and survival. These therapies can also enhance the immune system's ability to attack cancer cells. The TAEK-VAC-HerBy vaccine, which targets brachyury and HER2-expressing cells, represents a similar approach by aiming to stimulate an immune response against these specific cancer markers. Understanding these mechanisms is vital for breast cancer patients as it underscores the potential for targeted therapies to improve treatment outcomes and minimize side effects compared to conventional chemotherapy.

Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate.