Recruiting

Phase 1

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

Sponsor:

University of Washington

Code:

NCT07645651

Conditions

Resectable Pancreatic Ductal Adenocarcinoma

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Samuraciclib

Computed Tomography

Endoscopic Ultrasound Biopsy

Biospecimen Collection

Study Details

Brief summary:

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

Conditions

Resectable Pancreatic Ductal Adenocarcinoma

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Study ID

NCT07645651

Start date

Sep 15, 2026

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Jul 14, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (Samuraciclib)

Patients receive samuraciclib PO QD for 14 days on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will have a research EUS/FNB on study. Patients also undergo CT scans during screening and blood sample collection on study.

Interventions

Samuraciclib

Given PO

Computed Tomography

Undergo CT

Endoscopic Ultrasound Biopsy

Undergo EUS/FNB

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

Change in ribonucleic acid polymerase II serine levels [ Time Frame: Within 72 hours post versus pre-samuraciclib treatment ]

Central Contacts and Locations

Central contacts

Rachael Safyan, MD

206-606-2038 rsafyan@uw.edu

Isabel Blanco

206-606-5864 giresearch@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Rachael Safyan, MD

206-606-2038 rsafyan@uw.edu

Isabel Blanco

206-606-5864 giresearch@fredhutch.org

Principal Investigator:

Rachael Safyan, MD

More Information

Sponsor

University of Washington

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-20.