A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer

The goal of this phase 1 open label clinical trial is to evaluate the safety and preliminary efficacy of CodaLytic, an intratumorally-administered oncolytic virus, in patients with metastatic or otherwise inoperable breast cancer.The main questions it aims to answer are:How safe is CodaLytic when administered in escalating dosing groups into targeted lesions?What is the impact of CodaLytic on lesion response and disease progression?Eligible participants will be enrolled into four (4) escalating dose groups and treated with Codalytic through injection into a selected lesion(s) over twelve (12) weeks and then followed for up to one (1) year after the first dose. A safety committee will review the safety profile of each dosing group before the next dose-escalation.Study procedures will include physical examinations, injection site assessments, biopsies, imaging, and collection of blood/urine to assess safety, the body's immune response, and efficacy.

Inclusion Criteria:Women or men with metastatic or inoperable, histologically confirmed breast cancerHas no alternative treatment of proven benefit available or has refused treatmentExpected survival ≥ 3 monthsAt least 2 measurable lesions according to RECIST 1.1, without contraindication for repeated injections and core needle biopsiesAdequate organ functionEastern Cooperative Oncology Group performance status of 0 to 2Negative pregnancy test, if femaleAgreement to practice a highly effective method of contraceptionAgreement to no sperm donation through 28 days, if maleWilling to provide consent to perform study proceduresExclusion Criteria:Pregnant or lactating womenAnticancer therapy within 3 weeks of dosingKnown 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 ProductUncontrolled or severe cardiovascular diseaseImmunodeficiency 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 stableHistory of severe reaction (ie, anaphylaxis) to vaccination or immunotherapyPlanned radiation to lesions targeted for assessment/injection within 60 days before first dose or any planned radiation during dosing periodAny 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