Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
Phase I Study of Mesenchymal Stromal Cells-Derived Exosomes With KrasG12D siRNA for Metastatic Pancreas Cancer Patients Harboring KrasG12D Mutation
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.
PRIMARY OBJECTIVES: I. To identify the maximum tolerated dose (MTD) of mesenchymal stem cell (MSC)-derived exosomes loaded with small interference RNA (siRNA) against KrasG12D (iExosomes) in metastatic pancreatic ductal adenocarcinoma (PDAC) patients with KrasG12D mutation. II. To identify the dose-limiting toxicities (DLT) of mesenchymal stem cell (MSC)-derived exosomes loaded with siRNA against KrasG12D (iExosomes) in metastatic PDAC patients with KrasG12D mutation. SECONDARY OBJECTIVES: I. Evaluate the pharmacokinetic profile of iExosomes. II. Assess the overall response rate of iExosomes in the chosen patient population. III. Assess the disease control rate (partial response + stable disease) with therapy. IV. Determine median progression-free survival (PFS) with this treatment. V. Determine the median overall survival (OS) with this treatment. EXPLORATORY OBJECTIVES: I. Evaluate optional tissue collection and serum-derived exosomes and circulating-free deoxyribonucleic acid (DNA) (cfDNA) for detection of DNA and ribonucleic acid (RNA) showing KrasG12D sequence; evaluate DNA and RNA showing KrasG12D sequence in optional tissue collection. II. Evaluate the siRNA content in blood and optional tissue collection. OUTLINE: This is a dose-escalation study. Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA intravenously (IV) over 15-20 minutes on days 1, 4, and 10. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants who respond may continue 3 additional courses. After completion of study treatment, participants are followed up at 30 days, then every 3 months for up to 1 year. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05209074 -
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
|
Phase 1 | |
| Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT04969731 -
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03257150 -
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
|
N/A | |
| Terminated |
NCT04400903 -
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
|
||
| Recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03267316 -
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
| Terminated |
NCT04046887 -
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
|
Phase 1 | |
| Recruiting |
NCT05964621 -
Venous Thromboembolism in Primary Pancreatic Tumour Resection
|
||
| Active, not recruiting |
NCT04827953 -
Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
| Recruiting |
NCT05977322 -
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
| Recruiting |
NCT04862260 -
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
|
Early Phase 1 | |
| Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
| Completed |
NCT03770117 -
Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
|
||
| Completed |
NCT02259114 -
A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
|
Phase 1 |