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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

Summary

This trial is testing a new vaccine for patients with advanced cancer. The vaccine will be given intravenously, and patients will be monitored to see if it is effective.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients with Dose Limiting Toxicity (DLT)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Stage 2: HER2-positive Gastric/GEJ cancer cohort (Trastuzumab + TAEK-VAC-HerBy)Experimental Treatment1 Intervention
TAEK-VAC-HerBy will be administered intravenously to HER2-positive gastric/GEJ cancer patients who are on stable dose of trastuzumab. TAEK-VAC-HerBy will be administered every three weeks with
Group II: 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 III: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + Pertuzumab + TAEK-VAC-HerBy)Experimental Treatment1 Intervention
TAEK-VAC-HerBy will be administered intravenously to patients who are on stable dose of trastuzumab and pertuzumab. TAEK-VAC-HerBy will be administered every three weeks with three administrations in total at the dose defined in stage 1.
Group IV: 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 V: 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 VI: 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 VII: 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 VIII: 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.

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.

Find a Location

Who is running the clinical trial?

Bavarian NordicLead Sponsor
61 Previous Clinical Trials
49,873 Total Patients Enrolled
2 Trials studying Breast Cancer
24 Patients Enrolled for Breast Cancer
Mary (Nora) L Disis, MDPrincipal InvestigatorUniversity of Washington Medicine Seattle
1 Previous Clinical Trials

Media Library

TAEK-VAC-HerBy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04246671 — Phase 1
Breast Cancer Research Study Groups: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E9 Inf.U), Stage 2: Chordoma Cancer Cohort, Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy), Stage 2: HER2-positive Gastric/GEJ cancer cohort (Trastuzumab + TAEK-VAC-HerBy), Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + Pertuzumab + TAEK-VAC-HerBy), Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E10 Inf.U), Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E7 Inf.U), Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E8 Inf.U)
Breast Cancer Clinical Trial 2023: TAEK-VAC-HerBy Highlights & Side Effects. Trial Name: NCT04246671 — Phase 1
TAEK-VAC-HerBy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246671 — Phase 1
~11 spots leftby Jul 2025