Status: Closed
Activation Date: 2014OCT31
Closing Date: 2019APR11
Phase: I-II
Description: 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
Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years.
Objective: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to determine the recommended dose/schedule of MG1MA3 when AdMA3 has been administered first as priming therapy and to determine the safety, tolerability, adverse events (side effects) and immune and anti-tumour activity. Additional research will investigate viral delivery, replication and shedding in blood, tissue, urine, stool and saliva samples taken during the study.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I214 | 56 | 56 | 54 | 56 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I214 | 56 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I214 | 56 | 48 | 0 | 0 | 0 | 0 | 56 | 46 | 0 |