iExosomes for Metastatic Pancreatic Cancer with KrasG12D Mutation
This study is testing a treatment called mesenchymal stromal cells-derived exosomes with KRAS G12D siRNA (iExosomes) for people with pancreatic cancer that has spread (metastatic) and has a specific gene change called KrasG12D. The main goals are to find the safest and most effective dose of iExosomes and to see how well it works in treating the cancer. You may be able to join if you are 18 or older, have metastatic pancreatic cancer with the KrasG12D mutation, and your cancer has either progressed or been stable after at least one other treatment. The study aims to enroll 28 participants.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of the treatment to find the best amount. The study plans to enroll 28 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to one year to measure how long they live and if their minimal residual disease rate changes.
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NCT03608631
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~28 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose Determined by Dose Limiting Toxicity
Measured over First 4 weeks of treatment
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Brandon Smaglo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma harboring KrasG12D mutation
Patients must have documented progression or stable disease on one or more lines of systemic therapy. If stable disease, patient must have completed at least 4 months of chemotherapy with cytotoxic therapy
KrasG12D mutation status will be informed from any previous routine molecular profiling (using commercial assays such as Foundation One, Caris, Oncomine or other) of tissue or blood. Additional KrasG12D mutation status may be confirmed using tissue biopsy or blood prior to enrolling into the trial
ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Absolute neutrophil count (ANC) more or equal to 1,500 cells/mm3
Platelets more or equal to 100,000/ul
Hemoglobin more than 9.0 g/dL
Total bilirubin between 1 and 1.5 mg/dL
AST (aspartate aminotransferase) and ALT (alanine transaminase) less than 2.5 x ULN (upper limit of normal)
Alkaline phosphatase less than 2.5 x ULN
Creatinine less than 1.5 gm/dL
In patients with known Gilbert's syndrome, direct bilirubin less or equal to 1.5 x ULN will be used as organ function criteria, instead of total bilirubin
Negative serum pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
Exclusion
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection
Pregnancy (positive pregnancy test) or lactation
Known CNS (central nervous system) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging-MRI or computerized tomography-CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
What this trial measures
- Maximum Tolerated Dose Determined by Dose Limiting ToxicityFirst 4 weeks of treatment
Dose limiting toxicity graded according to the NCI CTCAE, Version 4.0
- Minimal residual disease rate in high-risk patientsUp to 1 year
Will be modeled using logistic regression.
- Overall survival (OS)Up to 1 year
Estimated using the Kaplan-Meier product limit estimator.
- Progression-free survival (PFS)Up to 1 year
Estimated using Kaplan-Meier product limit estimator.