NCT02364492: MAGTRIVACSEIN

An Open Label First-in-Human Adjuvant Phase I Study of a Synthetic Multiple Antigenic Glycopeptide Displaying a Tri Tn Glycotop (MAG-Tn3) Plus AS15, as a Therapeutic Vaccine Candidate in Patients With Non Metastatic, HER2 Negative Localized Breast Cancer at High-Risk of Relapse

Completed Phase 1 Last updated 21 March 2022

What this trial tests

Phase 1 trial testing MAG-TN3 + AS15 in Breast Neoplasms in 20 participants. Completed in 11 November 2021.

Timeline

1 February 2015

Primary endpoint
1 October 2019

11 November 2021

Quick facts

Lead sponsor	Institut Pasteur
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 February 2015
Primary completion	1 October 2019
Estimated completion	11 November 2021
Sites	5 locations across France

Drugs / interventions tested

• MAG-TN3 + AS15 — full drug profile →

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Institut Pasteur — full company profile →

Who can join

Adults 18 to 70, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To assess the number of patient(s) presenting dose-limiting toxicities (DLTs) from the first vaccine injection in the first patient of the dose cohort till 3 weeks after the second vaccine injection of the last patient of the dose cohort.
  Time frame: 3 weeks after 2 study vaccine injections corresponding to visit number 5.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunomodulatory Nanosystems.
   Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101
2. Glycosylation: mechanisms, biological functions and clinical implications.
   He M, Zhou X, Wang X. · · 2024 · cited 248× · PMID 39098853 · DOI 10.1038/s41392-024-01886-1
3. Trial Watch: Immunostimulation with Toll-like receptor agonists in cancer therapy.
   Iribarren K, Bloy N, Buqué A, Cremer I, et al · · 2016 · cited 98× · PMID 27141345 · DOI 10.1080/2162402x.2015.1088631
4. Targeting Tumor Glycans for Cancer Therapy: Successes, Limitations, and Perspectives.
   Berois N, Pittini A, Osinaga E. · · 2022 · cited 96× · PMID 35158915 · DOI 10.3390/cancers14030645
5. Immunotherapy for HER2-positive breast cancer: recent advances and combination therapeutic approaches.
   Ayoub NM, Al-Shami KM, Yaghan RJ. · · 2019 · cited 69× · PMID 30697064 · DOI 10.2147/bctt.s175360
6. Interplay between Natural Killer Cells and Anti-HER2 Antibodies: Perspectives for Breast Cancer Immunotherapy.
   Muntasell A, Cabo M, Servitja S, Tusquets I, et al · · 2017 · cited 66× · PMID 29181007 · DOI 10.3389/fimmu.2017.01544
7. Therapeutic vaccines for breast cancer: Has the time finally come?
   Corti C, Giachetti PPMB, Eggermont AMM, Delaloge S, et al · · 2022 · cited 55× · PMID 34823982 · DOI 10.1016/j.ejca.2021.10.027
8. The fully synthetic glycopeptide MAG-Tn3 therapeutic vaccine induces tumor-specific cytotoxic antibodies in breast cancer patients.
   Rosenbaum P, Artaud C, Bay S, Ganneau C, et al · · 2020 · cited 42× · PMID 32034426 · DOI 10.1007/s00262-020-02503-0