Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus

Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.

Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.

Inclusion Criteria:

• Surgically treated M0 patients with solid tumors
• Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
• A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
• Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
• 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
• Karnofsky over 70%
• No other concomitant malignancy

Exclusion Criteria:

• History of anaphylaxis or severe allergic reaction
• Severe heart, lung, kidney, liver or psychiatric condition
• Concurrent immunosuppressive therapy or impaired immune system