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

NCT07645651 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: RG1126054NCI-2026-0173321300
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 72 hours post versus pre-samuraciclib treatment

Secondary Outcomes (6)

• Incidence of samuraciclib-related adverse events

  Within 30 days of the last dose of samuraciclib

• Completion of 14 days of study drug (Feasibility)

  Up to 90 days

• Completion of the on-protocol research endoscopic ultrasound/fine needle biopsy (Feasibility)

  Up to 90 days

• Adequate biopsy (≥ 3 cores with ≥30% tumor cellularity) (Feasibility)

  Up to 90 days

• Time (days) from last dose of study drug to first definitive therapy (surgery or cycle 1 day 1 of neoadjuvant chemotherapy)

  Up to 90 days

Study Arms (1)

Treatment (Samuraciclib)

EXPERIMENTAL

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.

Drug: Samuraciclib; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound Biopsy; Procedure: Biospecimen Collection

Interventions

Samuraciclib DRUG

Given PO

Also known as: CDK7 Inhibitor CT7001, CT 7001, CT-7001, CT7001

Treatment (Samuraciclib)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (Samuraciclib)

Endoscopic Ultrasound Biopsy PROCEDURE

Undergo EUS/FNB

Treatment (Samuraciclib)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Samuraciclib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Serum creatinine ≥ 1.5X upper limit of normal (ULN) or serum creatinine clearance ≥ 50 ml/min by Cockcroft-Gault (within 14 days prior to study drug)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Lopker Family Foundation: collaborator
• Carrick Therapeutics Limited: collaborator
• The V Foundation for Cancer Research: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Rachael Safyan, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael Safyan, MD

CONTACT

206-606-2038; rsafyan@uw.edu

Isabel Blanco

CONTACT

206-606-5864; giresearch@fredhutch.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)