Pancreatic Cancer Clinical Trial
Official title:
Phase I - Escalating Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Locally Advanced Adenocarcinoma of the Pancreas, and a Single Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Non-operable Adenocarcinoma of the Pancreas
Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable
adenocarcinoma of the pancreas.
The primary endpoint:
To assess efficacy and local distribution of siRNA out of eight high dose siG12D LODERs in
patients diagnosed with operable adenocarcinoma of the pancreas.
The Secondary endpoint:
Short term tolerability and safety assessment
Phase I - This study is designed to investigate the safety of siG12D LODER (Local Drug
EluteR) in patients diagnosed with adenocarcinoma of the pancreas.
The primary endpoint:
To asses efficacy of siG12D LODER and local distribution in non-operable patients by
histopathology measurements, local distribution by RNA analysis.
To define the dose-limiting toxicities (DLT)
The Secondary endpoint
1. To determine the recommended Phase II dose (RP2D)
2. To define and maximum tolerated dose (MTD)
3. In the event of surgery, assessment of siG12D LODER local distribution and efficacy will
be based on histopathology measurements and RNA analysis.
4. Progression free survival - only by long term follow-up
The investigational agent siG12D LODER (Local Drug EluteR) is a miniature biodegradable
polymeric matrix that encompasses anti KRASG12D siRNA (siG12D) drug, designed to release the
drug regionally within a pancreatic tumor, at a prolonged rate of 12-16 weeks.
The majority of pancreatic ductal adenocarcinomas involve mutations in the KRAS oncogene (the
most common is G12D), therefore stable administration of KRASG12D siRNA has the potential to
silence and lead to apoptosis of such cancer cells and thereby slow and even halt the tumor
growth.
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