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 will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose levels will be explored to determine the recommended dose of TAEK-VAC-HerBy for Stage 2 of the trial. Stage 2 will enroll either chordoma patients for treatment with TAEK-VAC-HerBy alone, or HER2- positive breast cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose defined in stage 1. During stage 2, it may also be administered concurrently with a HER2 antibody(ies) (trastuzumab, pertuzumab).
Mayo Clinic - Phoenix
Scottsdale, Arizona, United States
Providence Saint John's Health Center
Santa Monica, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Georgia Cancer Center Augusta University
Augusta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Providence Cancer Institute
Portland, Oregon, United States
University of Washington
Seattle, Washington, United States
Patients with Dose Limiting Toxicity (DLT)
Frequency of patients with DLTs
Time frame: DLT evaluation period is 30 days after the last vaccine dose
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