A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer (NCT05600582) | Clinical Trial Compass
WithdrawnPhase 1
A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer
Stopped: Due to funding decision by the sponsor
United States0Started 2023-01-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection
Timeframe: Dosing Period approximately 3 months from first dose
2
To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection
Timeframe: Dosing Period approximately 3 months from first dose
3
To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection
Timeframe: Dosing Period approximately 3 months from first dose