Clinical trial · Interventional
A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer
Phase 1 Study of CodaLytic, an Intratumoral Influenza-based Oncolytic Virus, in Patients With Metastatic or Otherwise Inoperable Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to funding decision by the sponsor
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CodaLytic | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 10e7 PFU dose 3 injections
- description
- 10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)
- interventionNames
- Biological: CodaLytic
- type
- EXPERIMENTAL
- label
- 10e7 PFU dose 5 injections
- description
- 10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)
- interventionNames
- Biological: CodaLytic
- type
- EXPERIMENTAL
- label
- 10e8 PFU dose 3 injections
- description
- 10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Any condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a participant's ability to give informed consent
References
Publications (0)
Data not yet available