TAEK-VAC-HerBy Vaccine for Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen byMary (Nora) L Disis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Bavarian Nordic

No Placebo Group

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.

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.

See 8 more

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.

See 3 more

Treatment Details

Interventions

TAEK-VAC-HerBy (Cancer Vaccine)

Trial OverviewThe 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

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.