NCT07645651
Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~15 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:SamuraciclibComputed TomographyEndoscopic Ultrasound BiopsyBiospecimen Collection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ribonucleic acid polymerase II serine levels
Measured over Within 72 hours post versus pre-samuraciclib treatment
Conditions
NCT07645651
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washingtonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Rachael Safyan, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Eligibility criteria
Inclusion
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
Must be 18 years or older
Ability to understand and willingness to sign a written informed consent document
Archival biopsy specimen collected within 3 months must be available. If not available, a diagnostic EUS/FNB will be performed during screening
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count (ANC) ≥ 1,500/mcL (within 14 days prior to study drug)
Platelets ≥ 100,000/mcL (within 14 days prior to study drug)
Hemoglobin ≥ 9 g/dL (within 14 days prior to study drug)
Creatinine clearance ≥ 50 ml/min by Cockcroft-Gault
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5X ULN (within 14 days prior to study drug)
Total bilirubin ≤ 1.5X ULN (within 14 days prior to study drug)
Participants must not be pregnant or nursing. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours of treatment initiation, where WOCBP are defined as all female participants between 18 - 55 years of age. Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception for up to 6 months after the final administered dose of investigational agent. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Exclusion
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
Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that precluded adequate absorption of samuraciclib
Uncontrolled seizures
Active infection
Active bleeding diatheses
Known active hepatitis B or hepatitis C infection
Breastfeeding or pregnancy
Receipt of systemic corticosteroids within 14 days before the first dose of study medication
Receipt of St. John's Wort within 21 days before the first dose of study medication or of another concomitant medication, herbal supplement, or food that was a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein activity within 21 days before the first dose of samuraciclib
Known hypersensitivity to samuraciclib or any excipient of the product
What this trial measures
- Change in ribonucleic acid polymerase II serine levelsWithin 72 hours post versus pre-samuraciclib treatment
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).