OncoMatch/Clinical Trials/NCT03608631
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
Is NCT03608631 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA for kras np_004976.2:p.g12d.
Treatment: Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: KRAS g12d
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy — metastatic
Lab requirements
Blood counts
ANC more or equal to 1,500 cells/mm3; Platelets more or equal to 100,000/ul; Hemoglobin more than 9.0 g/dL
Kidney function
Creatinine less than 1.5 gm/dL
Liver function
Total bilirubin between 1 and 1.5 mg/dL; AST and ALT less than 2.5 x ULN; Alkaline phosphatase less than 2.5 x ULN; 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
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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