drugset / Trial / NCT02364492

A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse

NCT02364492

Phase 1 Completed 20 enrolled Institut Pasteur
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks.

Timeline

Start
2015-02
Primary completion
2019-10
Completion
2021-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject MAG-Tn3 Vaccine 30 ug Intramuscular
Subject MAG-Tn3 Vaccine 100 ug Intramuscular
Subject MAG-Tn3 Vaccine 300 ug Intramuscular
Background AS15 Other / unclassified Intramuscular

Indications