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

NCT05600582 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

BIOLOGICAL

CodaLytic

CodaLytic is a virotherapeutic product based on the wild-type influenza strain A/California/07/2009

Sponsors & Collaborators

  • Codagenix, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-09-30
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600582 on ClinicalTrials.gov