An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or unresectable locally advanced malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The study will last approximately 104 weeks before starting long term follow up (FU).
Name: MVA-BN-Brachyury/ FPV-BrachyuryDescription: Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 monthsType: Biological
Description: Fraction of patients who experience a (Dose Limiting Toxicity) DLT.Measure: Patients with Dose Limiting Toxicity Time: up to 8 weeks
There is one SNP
Patients with T790M mutations may continue receiving osimertinib while receiving vaccine. --- T790M ---