A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer
Breast Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Oncolytic Virotherapy
Eligibility Criteria
Inclusion Criteria: Women or men with metastatic or inoperable, histologically confirmed breast cancer Has no alternative treatment of proven benefit available or has refused treatment Expected survival ≥ 3 months At least 2 measurable lesions according to RECIST 1.1, without contraindication for repeated injections and core needle biopsies Adequate organ function Eastern Cooperative Oncology Group performance status of 0 to 2 Negative pregnancy test, if female Agreement to practice a highly effective method of contraception Agreement to no sperm donation through 28 days, if male Willing to provide consent to perform study procedures Exclusion Criteria: Pregnant or lactating women Anticancer therapy within 3 weeks of dosing Known active central nervous system metastases (with some exceptions) Presence of a concurrent malignancy for which the natural history or treatment has the potential to interfere with the safety or efficacy assessment of the Investigational Product Uncontrolled or severe cardiovascular disease Immunodeficiency or use of therapies expected to impair the immune response within thirty (30) days of enrollment or during dosing. Ongoing toxicity > Grade 1 from prior treatment except those which are stable History of severe reaction (ie, anaphylaxis) to vaccination or immunotherapy Planned radiation to lesions targeted for assessment/injection within 60 days before first dose or any planned radiation during dosing period Any condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a participant's ability to give informed consent
Sites / Locations
- Dana Farber Cancer Institute
- Gabrail Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
10e7 PFU dose 3 injections
10e7 PFU dose 5 injections
10e8 PFU dose 3 injections
10e8 PFU dose 5 injections
10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)
10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)
10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)
10e8 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)