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.
Dana Farber Cancer Institute (+1 Sites)Codagenix, Inc