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New treatment option for Breast Cancer
Official title HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
ClinicalTrials.gov ID: NCT07441889
What this study is testing
What is HER2 FPBMC?
HER2 FPBMC is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years at the time of signing informed consent
- Expected survival ≥ 3 months in the judgment of the investigator
- ECOG PS 0-1
You likely can't join if
- Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation
- History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively...
- Inadequate cardiac function, as defined as any of the following:
- Uncontrolled angina or severe ventricular arrhythmias
- Clinically significant pericardial disease
- History of myocardial infarction (MI) in the last year before registration
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years at the time of signing informed consent
- Expected survival ≥ 3 months in the judgment of the investigator
- ECOG PS 0-1
- Adequate Organ Function per the following criteria (within 10 days of study registration):
- Absolute lymphocyte count ≥ 400/mm3
- Absolute neutrophil count ≥ 1000/mm3
- Platelets ≥ 75,000/mm3
- Hemoglobin ≥ 9g/dL
- Serum creatinine \< 2.0 mg/dL OR measured or calculated creatinine clearance ≥ 50 ml/mm
- Total bilirubin ≤ mg/dL
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 5.0 times normal
- Agreement to adhere to Lifestyle Considerations throughout study duration
- A diagnosis of either of the following: a. Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone...
- Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation
- History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week
- Inadequate cardiac function, as defined as any of the following:
- Uncontrolled angina or severe ventricular arrhythmias
- Clinically significant pericardial disease
- History of myocardial infarction (MI) in the last year before registration
- Class 3 or higher New York Heart Association Congestive Heart Failure
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine...
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration
- Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus.
- Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy
- Has a known history of active TB (Bacillus Tuberculosis)
- Has received a live vaccine within 30 days of study registration.
- Treatment with any investigational agent within 3 weeks prior to study registration
- Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin
- Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is...
- Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant Additional Exclusion Criteria for Patients with Prostate Cancer:
- Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions
- Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the...
- Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the...
- Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary...
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.