NCT07645651 Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer
| NCT ID | NCT07645651 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Washington |
| Condition | Resectable Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-09-15 |
| Primary Completion | 2027-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-09-15 with a primary completion date of 2027-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.
Eligibility Criteria
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
Contact & Investigator
Rachael Safyan, MD
PRINCIPAL INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
Who can join the NCT07645651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Resectable Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645651 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07645651 currently recruiting?
Yes, NCT07645651 is actively recruiting participants. Contact the research team at rsafyan@uw.edu for enrollment information.
Where is the NCT07645651 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT07645651 clinical trial?
NCT07645651 is sponsored by University of Washington. The principal investigator is Rachael Safyan, MD at Fred Hutch/University of Washington Cancer Consortium. The trial plans to enroll 15 participants.