TAEK-VAC-HerBy Vaccine for Cancer

Recruiting at 17 trial locations

Overseen By DeShara Eley-Abdullah, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bavarian Nordic

Must be taking: HER2 antibodies

Must not be taking: Systemic corticosteroids

Disqualifiers: CNS metastasis, Cardiomyopathy, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cancer vaccine called TAEK-VAC-HerBy for individuals with advanced brachyury cancer or HER2-positive breast cancer, both serious forms of cancer. The study will assess the vaccine's safety and determine the optimal dose. Suitable candidates include those with hard-to-treat tumors that cannot be surgically removed or treated with radiation and who are already undergoing certain cancer treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop all current medications, but any approved cancer therapy (except HER2 antibodies) must be completed at least 3 weeks or 5 half-lives for small molecule inhibitors before starting the trial. If you have HER2-positive cancer, you are required to continue taking HER2 antibodies (trastuzumab) during the study.

Is there any evidence suggesting that the TAEK-VAC-HerBy vaccine is likely to be safe for humans?

Research shows that the TAEK-VAC-HerBy vaccine remains in the early stages of safety testing. Currently, insufficient data from human trials exists to determine how well people tolerate it or what side effects it might cause.

In these early studies, the main goal is to find a safe dose and monitor for any immediate side effects. While some insights into safety may emerge, much remains unknown.

As this trial involves a new treatment, participants might experience unknown or unexpected effects. Anyone considering participation should consult their healthcare provider to discuss any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAEK-VAC-HerBy because it offers a novel approach to cancer treatment by using a virus-based vaccine designed to target cancer cells selectively. Unlike traditional treatments like chemotherapy, which can affect both healthy and cancerous cells, TAEK-VAC-HerBy aims to minimize damage to normal cells by focusing on cancer-specific targets. Additionally, this vaccine is designed to work alongside existing treatments like trastuzumab, potentially enhancing their effectiveness against HER2-positive breast cancer. By integrating this unique mechanism, TAEK-VAC-HerBy could provide a more targeted and less harmful treatment option for cancer patients.

What evidence suggests that the TAEK-VAC-HerBy vaccine might be an effective treatment for cancer?

Research shows that the TAEK-VAC-HerBy vaccine targets cancers with specific proteins called brachyury and HER2. In this trial, participants will receive TAEK-VAC-HerBy in various stages and dosages. Previous studies have found that treatments focusing on HER2 can be effective, especially when combined with other therapies like trastuzumab, which works well for HER2-positive breast cancer. The vaccine aims to help the immune system recognize and attack cancer cells. Early results from similar vaccines suggest they can trigger strong immune responses, potentially reducing the chance of cancer recurrence. However, since TAEK-VAC-HerBy is a new treatment, researchers are still gathering detailed information about its effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Mary (Nora) L Disis, MD

Principal Investigator

University of Washington Medicine Seattle

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My organ and bone marrow functions are normal.

I am currently being treated with HER2 antibodies like trastuzumab.

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

Exclusion Criteria

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

You should not have a weakened immune system.

I haven't taken high doses of steroids for more than 5 days in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive TAEK-VAC-HerBy vaccine intravenously every three weeks, with three administrations in total, following a 3+3 dose escalation scheme to determine the recommended dose for Stage 2.

9 weeks

3 visits (in-person)

Stage 2 Treatment

Chordoma patients receive TAEK-VAC-HerBy alone, and HER2-positive breast cancer patients receive TAEK-VAC-HerBy in combination with trastuzumab, administered intravenously every three weeks, with three administrations in total.

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation for Dose Limiting Toxicity (DLT) 30 days after the last vaccine dose.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAEK-VAC-HerBy

Trial Overview 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.

How Is the Trial Designed?

Group I: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy) Experimental Treatment 1 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 Cohort Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Bavarian Nordic

Lead Sponsor

Trials

67

Recruited

50,900+

Paul Chaplin

Bavarian Nordic

Chief Executive Officer since 2014

PhD in Immunology from Bristol University

Jean-Christophe May

Bavarian Nordic

Chief Medical Officer since 2020

PharmD and MBA

Published Research Related to This Trial

A study of 91 lung cancer patients treated at an integrative cancer center in Korea found that those receiving integrative cancer treatment (ICT) had a 50% lower mortality rate compared to those receiving only traditional Korean medicine (TKM).

Patients with advanced-stage lung cancer had significantly higher mortality rates, but the integration of TKM with conventional treatments showed potential survival benefits, indicating that ICT may enhance outcomes for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative cancer treatment may have a survival benefit in patients with lung cancer: A retrospective cohort study from an integrative cancer center in Korea. Bae, K., Kim, E., Kong, JS., et al.[2022]

The combination of tipapkinogene sovacivec (TG4001) and avelumab was found to be safe for HPV16+ cancer patients, with no dose-limiting toxicities reported and most treatment-related adverse events being mild (grade 1/2).

In this study involving 43 heavily pretreated patients, the overall response rate was 22%, with a median overall survival of 11 months, indicating that this treatment can provide antitumor activity even in advanced cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers. Borcoman, E., Lalanne, A., Delord, JP., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04246671

NCT04246671 | TAEK-VAC-HerBy Vaccine for Brachyury ... A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer.

2. trials.braintumor.org trials.braintumor.org/trials/NCT04246671

TAEK-VAC-HerBy Vaccine for Brachyury and HER2 ... A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/her2-positive-breast-cancer

HER2-Positive Breast Cancer Clinical Trials This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608270/

Therapeutic vaccines for breast cancer: Has the time finally ... In conclusion, the clinical trial demonstrated that completion of the GP2+GM-CSF PIS safely elicited an immune response and reduced recurrence rates to 0% in ...

5. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04246671/

Clinical Trial: NCT04246671 A Phase 1/2 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced HER2- expressing cancer.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36997583/

Preclinical development of a first-in-class vaccine encoding ... Here we report the development of TAEK-VAC-HerBy (TVH), a first-in-class human tumor antibody enhanced killing (TAEK) vaccine based on the non- ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20490571

A Study to Evaluate Intravenous TAEK-VAC-HerBy Vaccine ... The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 ...