CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer (NCT05081492) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer
United States9 participantsStarted 2021-10-18
Plain-language summary
This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells and break them down.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* Agreement to research biopsies on study, once during study and end of study, exceptions may be granted with study principal investigator (PI) approval
* \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) =\< 10% by immunohistochemistry (IHC) and HER2 negative, per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Measurable disease by RECIST 1.1
* Patients must have progressed on or been intolerant of at least 2 prior lines of therapy for advanced/metastatic disease. Patients that qualify for immunotherapy and/or PARP inhibitors must have progressed on or been intolerant of these agents
* Fully recovered from the acute toxic effects (except alopecia) to =\< grade 2 to prior anti-cancer therapy
* Must have a superficial tumor (cutaneous, subcutaneous), breast lesion or nodal metastases amenable to safe repeated intratumoral injections per treating physician and interventional radiologist review
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
* P…