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Ad-MAGEA3 · 1 trial · 1 indication
To determine the maximum tolerated dose MTD/ maximum feasible dose MFD of Ad/MAGEA3 and MG1-MAGEA3 in combination with pembrolizumab
To evaluate objective tumour response rate (ORR) based on RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Ad/MAGEA3, MG1-MAGEA3 and pembrolizumab | EXPERIMENTAL | Ad-MAGEA3 prime will be administered as a single IM dose on Day 1 at 2 x 10e11 VP. MG1/MAGEA3 boost will be administered IV on Day 15 and Day 18 by 5 cohorts: Cohort 1: Days 15 \& 18 at 1x 10e10 pfu. Cohort 2: Days 15 \& 18 at 1x 10e11 pfu. Cohort 3: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 4: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 5: Day 15 at 3x 10e11 pfu; Day 18 at 3 x 10e12 pfu. Pembrolizumab will be administered IV every 3 weeks starting on Day 22. |
| Name | Type | Description |
|---|---|---|
| Ad-MAGEA3 | BIOLOGICAL | Intramuscular injection |
| MG1-MAGEA3 | BIOLOGICAL | Intravenous infusion |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) with positive expression of MAGE-A3 (primary or metastatic lesion). 2. Phase 1: Have radiographic progressi...
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Ad-MAGEA3 is an investigational therapy being studied in non-small cell lung cancer. It was evaluated in a Phase 1 trial in combination with pembrolizumab for patients with this disease. The trial has been completed.
Ad-MAGEA3 is being developed by Turnstone Biologics Corp., which trades under the ticker TSBX. The company is responsible for the clinical development of this agent.
Ad-MAGEA3 is in Phase 1 clinical development. It has been evaluated in a single Phase 1 trial, which is now completed. No Phase 2 or later trials have been reported.
Ad-MAGEA3 has been studied in one clinical trial: NCT02879760, a Phase 1 study titled Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients. The trial enrolled 16 participants in Canada and is completed.
No, Ad-MAGEA3 is not FDA approved. It is an investigational product that has completed a Phase 1 clinical trial and has not received marketing authorization for any indication.