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New treatment option for KRAS NP_004976.2:p.G12D
Official title iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
ClinicalTrials.gov ID: NCT03608631
What this study is testing
What is Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA?
Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kras np_004976.2:p.g12d.
Also referred to as MSC-derived Exosomes with KrasG12D siRNA (SY); KrasG12D siRNA-loaded Mesenchymal Stromal Cells-derived Exosomes (SY).
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
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
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
- 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...
- KrasG12D mutation status will be informed from any previous routine molecular profiling (using commercial assays such as Foundation One, Caris...
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
- Absolute neutrophil count (ANC) more or equal to 1,500 cells/mm3
You likely can't join if
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Houston, Texas, 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.