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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dlt evaluation period is 30 days after the last vaccine dose
Awards & highlights
Study 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 belowSelect...
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.
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
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are normal.I have a history of lung inflammation or scarring not caused by infections.You should not have a weakened immune system.I am currently being treated with HER2 antibodies like trastuzumab.I haven't taken high doses of steroids for more than 5 days in the last 2 weeks.I finished my last cancer treatment at least 3 weeks ago, or 5 half-lives ago for specific drugs.My cancer can be measured on a scan.I do not have severe heart issues, uncontrolled high blood pressure, or recent strokes.I am 18 years old or older.I have recovered from major side effects of my previous treatments.You have had an allergic reaction to a vaccine that contains vaccinia virus, aminoglycoside antibiotics, ciprofloxacin, or egg products in the past.I have received less than the maximum allowed dose of doxorubicin or epirubicin.My brain metastases are stable after treatment, with no new growth on recent scans.My heart pumps blood normally.My cancer cannot be removed by surgery and has spread.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E9 Inf.U)
- Group 2: Stage 2: Chordoma Cancer Cohort
- Group 3: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy)
- Group 4: Stage 2: HER2-positive Gastric/GEJ cancer cohort (Trastuzumab + TAEK-VAC-HerBy)
- Group 5: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + Pertuzumab + TAEK-VAC-HerBy)
- Group 6: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E10 Inf.U)
- Group 7: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E7 Inf.U)
- Group 8: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E8 Inf.U)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited for participation in this clinical trial?
"Affirmative. The details on clinicaltrials.gov verify that this experiment is currently recruiting subjects; the protocol was first uploaded to the platform on August 10th 2020., and has since been updated as of October 27th 2022. In total, 55 individuals are required between 17 distinct medical facilities."
Answered by AI
Does this study currently have an open enrollment period?
"Affirmative. Data found on clinicaltrials.gov suggests that this study is seeking participants, with the original trial being posted on August 10th 2020 and amended as recently as October 27th 2022. The researchers are looking to recruit 55 patients from 17 sites for this experiment."
Answered by AI
To what extent is this trial being administered at various medical facilities?
"At the moment, 17 clinical trial sites throughout America are recruiting patients for this study. These locations include Santa Monica, Rochester and Jacksonville as well as 14 other cities. To reduce travel stressors, it is advised that participants select a location closest to them."
Answered by AI
Is TAEK-VAC-HerBy a reliably secure option for individuals?
"The safety of TAEK-VAC-HerBy has been evaluated as a level 1 due to the limited clinical evidence available concerning its efficacy and potential side effects."
Answered by AI
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