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

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

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.

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

Recruitment

Summary

Participation Requirements

Description

Tracking Information