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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the TAEK-VAC-HerBy treatment for cancer?

The research suggests that integrative cancer treatments, which combine traditional and conventional methods, may improve survival rates in cancer patients. Additionally, herbal treatments like SH003 have shown potential in reducing tumor growth and spread in breast cancer, indicating that similar herbal-based therapies might be effective in cancer treatment. ^{1 2 3 4 5}

What makes the TAEK-VAC-HerBy treatment unique compared to other cancer treatments?

TAEK-VAC-HerBy is unique because it likely involves a novel combination of cancer vaccines and possibly oncolytic viruses, which are designed to stimulate the immune system to attack cancer cells more effectively. This approach may offer a new way to enhance the body's natural defenses against cancer, potentially improving outcomes compared to traditional treatments. ^{6 7 8 9 10}

Research Team

Mary (Nora) L Disis, MD

Principal Investigator

University of Washington Medicine Seattle

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness and Safety of Chinese Herbal Medicine Compound Kushen Injection as an Add-On Treatment for Breast Cancer: A Systematic Review and Meta-Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Chinese Herbal Medicine as an Adjunctive Therapy for Breast Cancer: A Systematic Review and Meta-Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Herbal extract SH003 suppresses tumor growth and metastasis of MDA-MB-231 breast cancer cells by inhibiting STAT3-IL-6 signaling. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[The orthogonal design study on tumor-inhibition and cancer-block role of Chinese medicinal 1023 co]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

The tipping point for combination therapy: cancer vaccines with radiation, chemotherapy, or targeted small molecule inhibitors. [2021]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A modular self-adjuvanting cancer vaccine combined with an oncolytic vaccine induces potent antitumor immunity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A novel dendritic cell-based cancer vaccine produces promising results in a syngenic CC-36 murine colon adenocarcinoma model. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Resident Memory T Cells as Surrogate Markers of the Efficacy of Cancer Vaccines. [2021]