NCT02285816

MG1 Maraba/MAGE-A3, With and Without Adenovirus Vaccine With Transgenic MAGE-A3 Insertion in Incurable MAGE-A3-Expressing Solid Tumours

A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients With Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because these viruses have been shown to shrink tumours in animals and human tumour samples by selectively killing cancer cells and creating an immune response to the tumour antigen contained in the viruses. This effect has been shown to increase when the AdMA3 virus is given first. It is not clear if this treatment will offer better results than standard treatment.

Detailed description

The purpose of the first phase of this study (phase I) is to find the dose of a new therapy, the MG1 Maraba/MAGE-A3 (MG1MA3) virus that can be given alone and in combination with the Adenovirus/MAGE-A3 (AdMA3) virus. In the first part of the study, patients may receive the Maraba virus, the Adenovirus or both viruses. To identify the highest safe dose of the Maraba virus alone or in combination the study will start at a dose lower than the one that does not cause side effects in animals. Participants are given one or both of these therapies and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If serious side effects are seen in patients at the first dose level, doses of MG1MA3 may be lowered in subsequent patients. If the side effects are not serious, then more potential participants are asked to join this study and are given higher doses. This will continue until the maximum feasible dose level is reached or one of the lower doses is found that causes serious but temporary side effects. Doses higher than that will not be given.

Conditions

• Advanced/Metastatic Solid Tumours

Interventions

Type	Name	Description
BIOLOGICAL	MG1MA3	MG1MA3: Boosting component of Oncolytic Vaccine
BIOLOGICAL	AdMA3	AdMA3: Priming component of Oncolytic Vaccine

Timeline

• Start date: 2015-01-22
• Primary completion: 2019-09-19
• Completion: 2026-12-31
• First posted: 2014-11-07
• Last updated: 2026-03-09

Locations

4 sites across 1 country: Canada