CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 28 target
Drug / intervention
Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNAdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed metastatic pancreatic ductal adenocarcinoma with KrasG12D mutation
  • ✓Documented progression or stable disease on one or more lines of prior systemic therapy; if stable disease, must have completed at least 4 months of chemotherapy with cytotoxic therapy
  • ✓ECOG performance status 0-1
  • ✓Signed informed consent
Key exclusion· 3
  • ✕Severe and/or uncontrolled medical conditions such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection
  • ✕Pregnancy or lactation
  • ✕Known CNS disease except treated brain metastases; neurosurgical resection or brain biopsy within 3 months prior to day 1 excluded

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03608631Phase 2RecruitingOn Track
Long Recruiting
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Phase I Study of Mesenchymal Stromal Cells-Derived Exosomes With KrasG12D siRNA for Metastatic Pancreas Cancer Patients Harboring KrasG12D Mutation

M.D. Anderson Cancer Center·interventional·Posted Aug 1, 2018·Updated May 20, 2026

In Brief

A Phase 2 clinical trial evaluating Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA for KRAS NP_004976.2:p.G12D and 3 related conditions. Currently recruiting, targeting 28 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKRAS NP_004976.2:p.G12D, Metastatic Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
201920202021202220232024202520262027
First PostedAug 1, 2018
Enrollment StartJan 27, 2021
Primary CompletionApr 30, 2027
TodayJul 1, 2026
Enrollment to primary: 6.3 yearsPosted 7.9 years agoPrimary completion in 10 months

Interventions

Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNAdrug

Given IV