Phase 1a Study to Evaluate Immunogenicity of ASV®

Inclusion Criteria

• •1. Signed, written informed consent.
• •2. Age ≥18 years.
• •3. Diagnosis of solid cancer that has been completely resected, NED, and eligible for observation only as SOC yet remain at risk of relapse per Investigator discretion. These include subjects diagnosed with malignant melanoma, non-small cell lung cancer, bladder cancer, colorectal cancer, breast cancer, renal cancer, head and neck cancer, cervical cancer, and soft tissue sarcoma.
• •4. Life expectancy ≥12 months from the time of consent.
• •5. Available fresh tissue from surgical excision. If fresh tissue is not available, formalin-fixed paraffin-embedded archival tissue may be used. The modality of the biopsy (e.g., endobronchial ultrasound, bronchoscopic, computed-tomography-guided needle biopsy) is not specified; however, core biopsy and fine needle aspiration are acceptable as long as the biopsy can be prepared as a cell block in paraffin-embedded tissue.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• •7. Adequate bone marrow function, as measured from studies of peripheral blood (absolute neutrophil count ≥1,500/mm3, absolute lymphocyte count ≥500/mm3, platelet count 50,000/mm3, hemoglobin \>8.0 mg/dL).
• •8. Adequate cardiac function (New York Heart Association class ≤II).
• •9. Female subjects of childbearing potential must have a negative serum pregnancy test at the screening and pretreatment visits, and prior to first dose of study medication. Non-childbearing potential (other than by medical reasons) is defined as 1 of the following:
• •1. ≥45 years of age and amenorrheic for \>1 year by self-report.
• •2. Amenorrheic for \>2 years without a hysterectomy and oophorectomy, and follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
• •3. Status post-hysterectomy, -oophorectomy, or -tubal ligation. If of childbearing potential, female subjects must be willing to use adequate birth control during the study, starting with the screening visit through 120 days after the last dose of study therapy.
• •Male subjects with a female partner(s) of childbearing potential must agree to use a condom throughout the trial, starting with the screening visit through 120 days after the last dose of study therapy. Male subjects with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
• •Note: Abstinence is acceptable for both female and male subjects if this is the subject's established and preferred contraception method.
• •10. Subject is willing and able to comply with the requirements of the protocol.