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Advanced/Metastatic Solid TumoursPhase 1/2NCT02285816

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

A Phase 1/2 study testing MG1MA3 and AdMA3 in people with Advanced/Metastatic Solid Tumours, run by Canadian Cancer Trials Group at 4 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Tumours
What is being tested?
MG1MA3 and AdMA3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesCanada
Study dates
22 Jan 2015to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PHASE I: Patients must have histologically confirmed, unresectable locally advanced/metastatic solid tumour with positive expression of MAGE-A3 (primary or metastatic lesion) and for which there is no known life prolonging standard therapy.
  • PHASE II: Patients must have histologically confirmed, unresectable locally advanced/metastatic solid tumour with positive expression of MAGE-A3 (primary or metastatic lesion) as follows:
  • Non-small cell lung cancer (NSCLC) specifically adenocarcinoma and squamous cell carcinoma.
  • Breast cancer
  • Esophageal/GEJ cancer/gastric
  • In phase II patients may be treated before refractory, such as while stable post treatment response to first line therapy.
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  • Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable by CT with IV contrast as follows:
  • Chest x-ray ≥ 20 mm
  • CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm-->Longest diameter
  • Physical exam (using calipers) ≥ 10 mm
  • Lymph nodes by CT scan ≥ 15 mm -->Measured in short axis
  • All radiology studies must be performed within 14 days prior to registration (within 21 days if negative).
  • Patients must have at least one additional tumour mass amenable to core needle or excisional biopsy (Note FNA is not acceptable) that is not a measurable lesion that will be used as a target lesion. Patients must consent to and be willing and able to undergo at least two core needle biopsies of that lesion.
  • Age ≥ 18 years
  • ECOG performance status of 0 or 1
  • Patients must have received at least one prior standard first line regimen for advanced or metastatic disease. The regimen may have been cytotoxic chemotherapy, targeted therapy, hormonal therapy (for e.g. anastrozole) or immunotherapy providing considered a standard first line therapy. There is no limit to the number of prior regimens but investigators and their patients should carefully consider the likelihood of benefit of an immunologic therapy in heavily pretreated patients.
  • For phase II, patients may be enrolled prior to disease progression, provided they have completed their first line therapy as below and they have documented stable disease on two consecutive tumour assessments (i.e. do not have evidence of tumour regression from therapy):
  • NSCLC patients may be entered after a minimum of 4-6 cycles of first line combination chemotherapy; if the patient is >70 years a single agent regimen is acceptable. If the patient has documented EGFR or ALK mutations, treatment they may have received may include an EGFR inhibitor or ALK inhibitor as first line therapy.
  • Breast cancer patients may be entered after a minimum of 6 cycles of first line therapy.
  • Patients with metastatic/recurrent esophageal carcinoma may be entered after first line chemotherapy for metastatic disease.
  • Washout period between last day of prior treatment and planned start of treatment is the longest of one of the following:
  • two weeks
  • standard cycle length of prior regimen
  • 10 half-lives for investigational drugs.
  • 30 days since last dose of ipilumumab or PR1/PDL1 therapy.
  • Patients must have recovered from any treatment related toxicities prior to registration (unless grade 1, irreversible and considered not clinically significant). Progression must be documented post radiotherapy if was given to the only site of measurable disease.
  • Patients may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Patients must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant).
  • Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred.
  • Laboratory requirements done within 7 days prior to registration:
  • WBC ≥ 3.0 x 10^9/L
  • absolute neutrophils ≥ 1.5 x 10^9/L
  • platelets ≥ 75 x 10^9/L
  • INR ≤ 1.2
  • bilirubin ≤ 1.5 x UNL (upper normal limit)
  • AST and ALT ≤ 3.0 x UNL or ≤ 5.0 x UNL if patient has liver metastases
  • serum creatinine ≤ 1.5 x UNL or creatinine clearance ≥ 60ml/min
  • serum phosphate > 0.8mMol/L (grade 0-1)
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to registration and prior to tests which are considered to be study specific
  • Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.
  • Pre-treatment biopsy must be done within 5 working days after registration and treatment is to begin within 5 working days of the pre-treatment biopsy (max. 10 working days from registration).

Who cannot join

  • Patients with a history of other active or current malignancies that require active treatment
  • Patients with known symptomatic brain metastases. Patients with treated and radiologic or clinical evidence of stable brain metastases, are eligible providing that they have been stable for at least 3 months, are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 month prior to entry).
  • Patients receiving concurrent treatment with other anti-cancer therapy or other investigational agents.
  • Patients who have had prior treatment with AdVAC, MG1MA3 or any MAGE-A3 targeted therapy.
  • Pregnant or lactating women. Men and women of childbearing potential who do not agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of the study participation.
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including, but not limited to:
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  • History of significant neurologic or psychiatric disorder (e.g. uncontrolled psychotic disorders) which would impair the ability to obtain consent or limit compliance with study requirements.
  • Active uncontrolled or serious infection (viral, bacterial or fungal) or a history of opportunistic infection associated with an immunodeficient state.
  • Significant immunodeficiency due to underlying illness (e.g. known HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
  • Known myeloproliferative disorders requiring systemic therapy.
  • Other medical conditions that might be aggravated by study treatment.
  • Patients with uncontrolled pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction.
  • Patients with household contacts meeting any of the following criteria are ineligible for study entry unless alternate living arrangements can be made:
  • Women who are pregnant or nursing an infant
  • Children < 12 months old
  • Anyone with significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
  • Use of anti-viral medication, steroids, immunosuppressive agents (cyclosporine, interferon) or immunization (including the flu shot) within 14 days prior to registration. Use of anti-viral, anti-platelet, or anti-coagulation medication that cannot be discontinued within 14 days of enrollment.
  • Patients with disease/tumour invading a major vascular structure (e.g. carotid artery), tumour related impending bowel obstruction or clinically significant and/or rapidly accumulating ascites, pericardial or pleural effusions.
  • Patients with conditions likely to have resulted in splenic dysfunction (e.g. splenectomy, sickle cell anemia, radiation to the spleen ≥ 20Gy, congenital asplenism).
  • Patients with ≥ grade 2 dyspnea and/or requirement for supplemental oxygen. Patients with important pulmonary disease must complete a 6 minute ambulation test with O2 states ≥ 90% to be eligible

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
MG1MA3, AdMA3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MG1MA3Biological

    Also called MG1 Maraba/MAGE-A3

    MG1MA3: Boosting component of Oncolytic Vaccine

  • AdMA3Biological

    Also called Adenovirus/MAGE-A3

    AdMA3: Priming component of Oncolytic Vaccine

Study groups in NCT02285816
Study groupRoleWhat they receive
Arm A (MG1MA3 virus alone)ExperimentalThe starting dose of MG1MA3 will be 1 x 10^10 pfu administered by IV on day 1 and day 4.MG1MA3 dose will be escalated as per protocol.
Receives: Biological: MG1MA3
Arm B- AdMA3 (vaccine prime) aloneExperimentalSix patients will receive prime AdMA3 vaccine at a dose of 1x10^10 pfu administered IM on day (-14). No dose escalation is planned.
Receives: Biological: AdMA3
Arm C- AdMA3 plus MG1MA3 (prime + boost)ExperimentalPrime AdMA3 vaccine will be administered as a single dose of 1x10^10 pfu IM at day (-14) followed by dose escalation of MG1MA3 boost, IV administered on days 1 \& 4 at a starting dose of 1 log below the recommended phase II dose (RP2D), as determined in Arm A of this study. MG1MA3 dose will be escalated as defined in protocol.
Receives: Biological: MG1MA3; Biological: AdMA3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Toxicity as measured by adverse events

    To Determine maximum feasible dose (MFD) of:

    • MG1MA3 when administered alone on day 1 \& day 4 (Arm A)
    • MG1MA3 when administered on day 1 \& 4 or days 1, 4, 8 \&11 following immunologic priming with AdMA3 (Arm C)
    • To confirm the safety profile of AdMA3 administration (Arm B).

    Measured: 3 years

  2. Phase II: Objective tumour response rate (ORR) using RECIST v1.1.

    To evaluate the objective tumour response rate (ORR) using RECIST v1.1.

    Measured: 16 weeks

Secondary outcomes (9)

  1. Phase I: Number and Severity of Adverse Events in patients

    To determine the safety profile of:

    • MG1MA3 when administered alone (Arm A);
    • MG1MA3 when administered on day 1 \& 4 or days 1, 4, 8 \&11 following immunologic priming with AdMA3 (Arm C). Adverse events will be monitored on an ongoing basis by the central office and their frequencies reported semi-annually at investigators' meetings. Toxic effects will be categorized using the CTCAE. The worst event for each patient in each category or subcategory will be described. Both events related and unrelated to treatment will be captured.

    Measured: 8 weeks

  2. Phase I: MG1MA3 clearance and secondary replication from pharmacokinetics and viral shedding

    To determine the pharmacokinetics, including viral shedding, of MG1MA3 when administered:

    • Alone on day 1 \& day 4 (Arm A);
    • Following immunologic priming with AdMA3 (Arm C). Pharmacokinetic parameters including MG1MA3 clearance and secondary replication (genomes and infectious units), will be evaluated in blood over time and summarized descriptively by treatment arms in phase I portion.

    Measured: 3 years

  3. Phase I: Delivery to, and viral detection and replication within, tumours for MG1MA3

    To determine the delivery to, and viral detection and replication within, tumours for MG1MA3 when administered:

    • Alone on day 1 \& day 4 (Arm A);
    • Following immunologic priming with AdMA3 (Arm C).

    Measured: 3 years

  4. Phase I: Cellular and humoral immune response to virus and tumour antigens

    To determine the cellular and humoral immune response to virus and tumour antigens (for all arms).

    Measured: 3 years

  5. Phase I: Efficacy using RECIST v1.1 and iRECIST

    To evaluate preliminary evidence of efficacy using RECIST v1.1 and iRECIST

    Measured: 3 years

  6. Phase II: pharmacokinetics (PK) of MG1MA3 (MG1MA3 clearance and secondary replication (genomes and infectious units)

    To further explore the pharmacokinetics (PK) of MG1MA3. Pharmacokinetic parameters including MG1MA3 clearance and secondary replication (genomes and infectious units), will be evaluated in blood over time and summarized descriptively by tumour types in phase II portion.

    Measured: 3 years

  7. Phase II: cellular and humoral immune response to virus and tumour antigens

    To further evaluate the cellular and humoral immune response to virus and tumour antigens.

    Measured: 16 weeks

  8. Phase II: toxicity as measured by adverse events of MG1MA3 following AdMA3

    To further explore the safety profile of MG1MA3 following AdMA3

    Measured: 3 years

  9. Phase II: Response by iRECIST

    To evaluate response by iRECIST

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study start22 Jan 2015
  3. Primary completion19 Sep 2019
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285816
Sponsor's protocol ID
I214
Status last verified
Mar 2026
First submitted
31 Oct 2014
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mullins-Dansereau V, Myre ML, Bardoul A, Geoffroy K, Rallo Pita MJ, Beland D, Desaulniers KL, Roy DG, Bourgeois-Daigneault MC. Oncolytic VSV-IL-2 has enhanced anticancer vaccination adjuvant abilities. J Immunother Cancer. 2025 May 19;13(5):e010570. doi: 10.1136/jitc-2024-010570.

    PubMed 40389376

  • Jenner AL, Cassidy T, Belaid K, Bourgeois-Daigneault MC, Craig M. In silico trials predict that combination strategies for enhancing vesicular stomatitis oncolytic virus are determined by tumor aggressivity. J Immunother Cancer. 2021 Feb;9(2):e001387. doi: 10.1136/jitc-2020-001387.

    PubMed 33608375

  • Pol JG, Acuna SA, Yadollahi B, Tang N, Stephenson KB, Atherton MJ, Hanwell D, El-Warrak A, Goldstein A, Moloo B, Turner PV, Lopez R, LaFrance S, Evelegh C, Denisova G, Parsons R, Millar J, Stoll G, Martin CG, Pomoransky J, Breitbach CJ, Bramson JL, Bell JC, Wan Y, Stojdl DF, Lichty BD, McCart JA. Preclinical evaluation of a MAGE-A3 vaccination utilizing the oncolytic Maraba virus currently in first-in-human trials. Oncoimmunology. 2018 Sep 19;8(1):e1512329. doi: 10.1080/2162402X.2018.1512329. eCollection 2019.

    PubMed 30546947

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MG1MA3 and AdMA3 in people with Advanced/Metastatic Solid Tumours, run by Canadian Cancer Trials Group at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Toxicity as measured by adverse events (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285816, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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