Viral Therapy for Cancer
Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Canadian Cancer Trials Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) before starting the treatment. This means you may need to stop taking some of your current medications, especially anti-viral, anti-platelet, or anti-coagulation medications, at least 14 days before enrolling in the study.
What data supports the effectiveness of the treatment AdMA3, MG1MA3 in the clinical trial 'Viral Therapy for Cancer'?
Is the viral therapy AdMA3/MG1MA3 safe for humans?
How does the treatment AdMA3, MG1MA3 differ from other cancer treatments?
The treatment AdMA3, MG1MA3 is unique because it uses viral therapy, specifically oncolytic viruses, to target and kill cancer cells. This approach allows the virus to replicate within tumor cells, increasing its numbers and spreading to infect more cancer cells, which is different from traditional therapies that do not involve viral replication.411121314
What is the purpose of this trial?
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.
Research Team
DJ
Derek Jonker
Principal Investigator
Ottawa Hospital Research Institute
Eligibility Criteria
Adults with certain advanced solid tumors expressing MAGE-A3, who've had at least one standard treatment. They must have measurable disease and be in good physical condition (ECOG 0 or 1). Excluded are those with active infections, other cancers needing treatment, significant medical issues, brain metastases requiring steroids, or pregnant/breastfeeding individuals.Inclusion Criteria
My cancer is advanced, cannot be surgically removed, and tests positive for MAGE-A3.
My cancer is advanced, cannot be surgically removed, and tests positive for MAGE-A3.
Exclusion Criteria
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: 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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase I Treatment
Participants receive MG1MA3 alone or in combination with AdMA3 to determine the maximum feasible dose and safety profile
8 weeks
Multiple visits for dose administration and monitoring
Phase II Treatment
Participants receive treatment to evaluate objective tumour response rate using RECIST v1.1
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Treatment Details
Interventions
- AdMA3
- MG1MA3
Trial Overview The trial is testing two viruses: MG1MA3 alone or followed by AdMA3. These have shown promise in killing cancer cells and boosting immune response against the tumor antigen they carry. The study aims to see if this approach works better than standard treatments.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm C- AdMA3 plus MG1MA3 (prime + boost)Experimental Treatment2 Interventions
Prime 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.
Group II: Arm B- AdMA3 (vaccine prime) aloneExperimental Treatment1 Intervention
Six patients will receive prime AdMA3 vaccine at a dose of 1x10\^10 pfu administered IM on day (-14). No dose escalation is planned.
Group III: Arm A (MG1MA3 virus alone)Experimental Treatment1 Intervention
The 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Trials
135
Recruited
70,300+
Ottawa Hospital Research Institute
Collaborator
Trials
585
Recruited
3,283,000+
Findings from Research
In a phase I trial involving 41 patients with recurrent glioblastoma (rGBM), the oncolytic herpes virus CAN-3110 was safely administered without dose-limiting toxicities, showing potential for preferential tumor replication due to its unique genetic modifications.
Patients with pre-existing HSV1 antibodies experienced improved survival and tumor response, suggesting that CAN-3110 can enhance immune responses against tumors even in challenging microenvironments, providing a promising avenue for treating cancers resistant to traditional immunotherapy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical trial links oncolytic immunoactivation to survival in glioblastoma.Ling, AL., Solomon, IH., Landivar, AM., et al.[2023]
In a pilot study involving 21 patients with advanced melanoma resistant to anti-PD-1 therapy, the combination of ONCOS-102 (an oncolytic adenovirus) and pembrolizumab was well tolerated, with most side effects being mild to moderate, such as fever and chills.
The treatment resulted in an objective response rate of 35%, with 53% of patients showing a reduction in size of non-injected tumors, indicating a systemic immune response and suggesting that ONCOS-102 effectively enhances T-cell infiltration and activity against melanoma.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti-PD-1-Resistant Advanced Melanoma.Shoushtari, AN., Olszanski, AJ., Nyakas, M., et al.[2023]
References
Expression of FMS-like tyrosine kinase 3 ligand by oncolytic herpes simplex virus type I prolongs survival in mice bearing established syngeneic intracranial malignant glioma. [2021]
Clinical trial links oncolytic immunoactivation to survival in glioblastoma. [2023]
Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti-PD-1-Resistant Advanced Melanoma. [2023]
Replicative oncolytic adenoviruses in multimodal cancer regimens. [2022]
Attenuated Dengue virus PV001-DV induces oncolytic tumor cell death and potent immune responses. [2023]
Ad3-hTERT-E1A, a fully serotype 3 oncolytic adenovirus, in patients with chemotherapy refractory cancer. [2021]
Review of Safety Data for Adenovirus 5 as a Delivery Vector for Intratumoral Cancer Gene Therapy. [2023]
A phase I/II study of triple-mutated oncolytic herpes virus G47∆ in patients with progressive glioblastoma. [2022]
Treatment of cancer patients with a serotype 5/3 chimeric oncolytic adenovirus expressing GMCSF. [2022]
A novel bicistronic high-capacity gutless adenovirus vector that drives constitutive expression of herpes simplex virus type 1 thymidine kinase and tet-inducible expression of Flt3L for glioma therapeutics. [2021]
Enhanced delivery of mda-7/IL-24 using a serotype chimeric adenovirus (Ad.5/3) improves therapeutic efficacy in low CAR prostate cancer cells. [2021]
Maraba MG1 virus enhances natural killer cell function via conventional dendritic cells to reduce postoperative metastatic disease. [2022]
Prostate-specific membrane antigen cleavage of vitamin B9 stimulates oncogenic signaling through metabotropic glutamate receptors. [2022]
Enhanced delivery of mda-7/IL-24 using a serotype chimeric adenovirus (Ad.5/3) in combination with the Apogossypol derivative BI-97C1 (Sabutoclax) improves therapeutic efficacy in low CAR colorectal cancer cells. [2022]
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