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New treatment option for Pancreas Cancer
Official title Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT06479239
What this study is testing
What is EGFR FPBMC?
EGFR FPBMC is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pancreas 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 combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 twice weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.
- 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
- Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not...
- Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a...
- Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Age ≥ 18 years
You likely can't join if
- Known hypersensitivity to cetuximab
- Treatment with investigational agent within 3 weeks prior to registration
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to...
- Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with...
- Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
- History of a myocardial infarction within 1 year prior to registration
See the full eligibility criteria
- Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy
- Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound...
- Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Age ≥ 18 years
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration
- Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain...
- Adequate organ function within 14 days prior to registration, defined as the following:
- Absolute neutrophil count \>= 500/mm3
- Absolute lymphocyte count \>= 400/mm3
- Platelets \>= 75,000/mm3
- Hemoglobin \>= 8 g/dL
- Serum creatinine \ = 50 ml/min
- Bilirubin \<= 2 mg/dL
- Aspartate transferase (AST) and Alanine transaminase (ALT) \<= 5.0 x upper limit of normal (ULN)
- Alpha gal \< 0.35 IU/ml or "negative"
- Ability to provide informed consent and provision of written informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adequate cardiac function as defined as:
- No uncontrolled angina or severe ventricular arrhythmias
- No clinically significant pericardial disease
- No history of myocardial infarction (MI) in the last year before registration
- No Class 3 or higher New York Heart Association Congestive Heart Failure
- Known hypersensitivity to cetuximab
- Treatment with investigational agent within 3 weeks prior to registration
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration
- Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed)
- Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
- History of a myocardial infarction within 1 year prior to registration
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial
- Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed)
- History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating...
- Females must not be currently breast feeding.
- The treating investigator feels the patient is not able to be compliant.
- History of active Bacillus Tuberculosis (TB).
- Has received a live vaccine within 30 days of registration.
- Prisoners or patients who are incarcerated.
- Patients who are compulsorily detained for treatment of a psychiatric or physical illness.
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.