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 range18 Years

SexALL

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…

What they're measuring

To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose

To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose

To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose

Trial details

NCT IDNCT05600582

SponsorCodagenix, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Breast Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose

To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose

To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection

Timeframe: Dosing Period approximately 3 months from first dose