Recruiting
Phase 1
Phase 2

EGFRBi

Sponsor:

University of Virginia

Code:

NCT06479239

Conditions

Pancreas Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EGFR FPBMC

Study Details

Brief summary:

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.

Conditions

Pancreas Cancer

Pancreatic Cancer

Study ID

NCT06479239

Start date

Nov 6, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy
2. 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 paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein/microsatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial.
3. Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
5. Age ≥ 18 years
6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration
7. 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 from sperm donations during study treatment and for at least 90 days after the last dose of study drug.
8. 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 < 2.0mg/dL or calculated/measured creatinine clearance >= 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"
9. Ability to provide informed consent and provision of written informed consent
10. Stated willingness to comply with all study procedures and availability for the duration of the study
11. 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

Exclusion Criteria:

1. Known hypersensitivity to cetuximab
2. Treatment with investigational agent within 3 weeks prior to registration
3. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration
4. 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)
5. Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
6. History of a myocardial infarction within 1 year prior to registration
7. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
8. 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)
9. 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 investigator
10. Females must not be currently breast feeding.
11. The treating investigator feels the patient is not able to be compliant.
12. History of active Bacillus Tuberculosis (TB).
13. Has received a live vaccine within 30 days of registration.
14. Prisoners or patients who are incarcerated.
15. Patients who are compulsorily detained for treatment of a psychiatric or physical illness.

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EGFR Fresh Peripheral Blood Mononuclear Cells

Participants will undergo apheresis to collect cells to make EGFR fresh peripheral blood mononuclear cells (FPBMC). These cells will be activated in the lab to fight against pancreas cancer. About 3-4 days after apheresis, participants will start receiving infusions of EGFR FPBMC. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression. Participants that have disease progression after the first 8 infusions may receive chemotherapy and then continue study treatment with the other 8 infusions.

Interventions

EGFR FPBMC

Participants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.

Primary outcome measure

  • Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only) [ Time Frame: Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment)) ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Tri Le, MD, DSc

More Information

Sponsor

University of Virginia

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-16.