Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Samuraciclib
  • Computed Tomography
  • Endoscopic Ultrasound Biopsy
  • Biospecimen Collection

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Washington

Lead sponsor

Lopker Family Foundation

Collaborator

Carrick Therapeutics Limited

Collaborator

The V Foundation for Cancer Research

Collaborator