The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.
Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei
Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of positron emission tomography (PET)/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis. The institutional radiologist must review the scans. Resectable, borderline resectable, and locally advanced will be defined by National Comprehensive Cancer Network (NCCN) guidelines version 2.2025.
There must be no evidence of metastatic disease
Prior radiation
Unable to tolerate oral medication, per assessment of the principal investigator (PI)
Participants who are receiving other investigational agents
Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy
Single group
Samuraciclib
DrugGiven PO
Computed Tomography
Procedure/SurgeryUndergo CT
Endoscopic Ultrasound Biopsy
Procedure/SurgeryUndergo EUS/FNB
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Change in ribonucleic acid polymerase II serine levels
Will be assessed by pharmacodynamic changes in primary tumor cells. Pre and post measurements will be compared using a paired t-test at the 2-sided 5% level. Data will be transformed as necessary (e.g. using log-transformation).
Incidence of samuraciclib-related adverse events
Will be measured by Common Terminology Criteria for Adverse Events version 6.
Completion of 14 days of study drug (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Completion of the on-protocol research endoscopic ultrasound/fine needle biopsy (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Adequate biopsy (≥ 3 cores with ≥30% tumor cellularity) (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
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University of Washington
Lead sponsor
Lopker Family Foundation
Collaborator
Carrick Therapeutics Limited
Collaborator
The V Foundation for Cancer Research
Collaborator
