Intravenous TAEK-VAC-HerBy Vaccine Alone and in Combination Treatment in HER2 Cancer Patients

Complete Title: Phase 1/2 expansion cohorts trial of intravenous administration of TAEK-VAC-HerBy vaccine alone and in combination with HER2- and PD-1/PD-L1 antibodies in patients with advanced HER2- expressing cancer

Trial Phase: I

Investigator: Nora Disis

A Phase 1/2 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced HER2- expressing cancer. The study will be completed in 3 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. Stage 2 will enroll patients with HER2- positive breast and gastric cancer to administer the TAEK-VAC-HerBy vaccine in combination with HER2 antibodies. Stage 3 will enroll patients to evaluate the safety and tolerability of the TAEK-VAC-HerBy vaccine in combination with HER2 antibodies and PD-1/PD-L1 antibody. Patients, in all three stages, will receive TAEK-VAC-HerBy every three weeks, three administrations in total.

Keywords:

Breast Cancer
Gastric Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Colorectal Neoplasms
Carcinoma, Merkel Cell
Carcinoma, Hepatocellular
Lung Carcinoma, Small-Cell

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