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

Summary

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.

Timeline

Start

2023-01-15

Primary completion

2024-09-30

Completion

2025-01-30

Outcome

Outcome not reported

Stopped (Business): “Due to funding decision by the sponsor”

Drugs

Indications