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

Official Title

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

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.

Trial Description

Primary Outcome:

  • Phase I: Toxicity as measured by adverse events
  • Phase II: Objective tumour response rate (ORR) using RECIST v1.1.
Secondary Outcome:
  • Phase I: Number and Severity of Adverse Events in patients
  • Phase I: MG1MA3 clearance and secondary replication from pharmacokinetics and viral shedding
  • Phase I: Delivery to, and viral detection and replication within, tumours for MG1MA3
  • Phase I: Cellular and humoral immune response to virus and tumour antigens
  • Phase I: Efficacy using RECIST v1.1 and iRECIST
  • Phase II: pharmacokinetics (PK) of MG1MA3 (MG1MA3 clearance and secondary replication (genomes and infectious units)
  • Phase II: cellular and humoral immune response to virus and tumour antigens
  • Phase II: toxicity as measured by adverse events of MG1MA3 following AdMA3
  • Phase II: Response by iRECIST
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society