Actively Recruiting
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
Led by M.D. Anderson Cancer Center · Updated on 2025-11-26
28
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.
CONDITIONS
Official Title
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma harboring KrasG12D mutation
- Documented progression or stable disease on one or more lines of systemic therapy, with at least 4 months of chemotherapy if stable
- KrasG12D mutation status confirmed by previous molecular profiling or biopsy prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Absolute neutrophil count (ANC) greater or equal to 1,500 cells/mm3
- Platelet count greater or equal to 100,000/µL
- Hemoglobin level more than 9.0 g/dL
- Total bilirubin between 1 and 1.5 mg/dL
- AST and ALT less than 2.5 times the upper limit of normal
- Alkaline phosphatase less than 2.5 times the upper limit of normal
- Creatinine less than 1.5 gm/dL
- In known Gilbert's syndrome, direct bilirubin less or equal to 1.5 times the upper limit of normal
- Negative pregnancy test for women of childbearing potential within one week before treatment
- Women of childbearing potential must use effective contraception during the study and for 12 weeks after last dose
- Male participants with potential to father children must use contraception during the study and for 12 weeks after last dose
- Signed informed consent acknowledging investigational nature and risks
You will not qualify if you...
- Severe or uncontrolled medical conditions such as unstable angina, recent heart attack within 6 months, unstable arrhythmia, uncontrolled diabetes, serious active infection
- Pregnancy or breastfeeding
- Known central nervous system disease except treated brain metastases without progression or hemorrhage and no ongoing need for dexamethasone
- Brain metastases treated by neurosurgery within 3 months prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Brandon Smaglo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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