Cancer-Killing virus trial launches for Hard-to-Treat breast cancer
NCT ID NCT05081492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment for metastatic triple-negative breast cancer, a type that has spread and is hard to treat. The treatment uses a specially designed virus that is injected directly into tumors to infect and destroy cancer cells. The main goal is to find the safest dose and understand side effects in about 9 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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9 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Platelets \>= 100,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement * Total bilirubin =\< 1.5 X upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 2.5 x ULN * If liver metastases are present: AST =\< 5 x ULN * Alanine aminotransferase (ALT) =\< 2.5 x ULN * If liver metastases are present: ALT =\< 5 x ULN * Serum creatinine =\< 1.5 mg/dL or creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula * Prothrombin (PT) =\< 1.5 x ULN * Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN * Women of childbearing potential (WOCBP): negative serum pregnancy test * Agreement by females and males of childbearing potential\* and their partners to use an effective method of birth control (defined as a hormonal or barrier method) or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Chemotherapy, biological therapy, immunotherapy or investigational therapy within 14 days prior to day 1 of protocol therapy * Major surgery or radiation therapy within 28 days of study therapy * Has received a vaccination within 30 days of first study injection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Clinically significant uncontrolled illness * Active infection requiring antibiotics * Known history of immunodeficiency virus (HIV) * Patients with a known history of hepatitis B or hepatitis C infection who have active disease as evidenced by hepatitis (Hep) B surface antigen status or Hep C polymerase chain reaction (PCR) status obtained within 14 days of cycle 1, day 1 * Another malignancy within 3 years, except non-melanomatous skin cancer * Females only: Pregnant or breastfeeding * Patients may not have clinically unstable brain metastases. Patients may be enrolled with a history of treated brain metastases that are clinically stable for \>= 4 weeks prior to start of study treatment * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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