Resectable Pancreatic Ductal AdenocarcinomaPhase 1NCT07645651
Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer
A Phase 1 study testing Samuraciclib, Computed Tomography and Endoscopic Ultrasound Biopsy in people with Resectable Pancreatic Ductal Adenocarcinoma and Borderline Resectable Pancreatic Ductal Adenocarcinoma, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Samuraciclib, Computed Tomography and Endoscopic Ultrasound Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Isabel Blanco, 206-606-5864, giresearch@fredhutch.org
Andrew Coveler, MD
About this study
Official title: Phase 1b Window-of-Opportunity Study Evaluating CDK7 Inhibition in Patients With Localized Basal Pancreatic Cancer
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.
Read the detailed description
This is a single-institution, single-arm, open-label, Phase 1 study designed to evaluate whether samuraciclib, a cyclin dependent kinase 7 inhibitor (CDK7), alters the cellular functioning of the pancreatic tumor cells.
OUTLINE:
Patients will receive samuraciclib orally (PO) once daily (QD) for 14 days on study following their diagnosis of pancreatic cancer and before starting chemotherapy or undergoing surgery for their cancer. Patients will undergo an endoscopic ultrasound (EUS) with fine needle biopsy (FNB) while on study.
After completion of study treatment, patients are followed up at 30 and 90 days.
- Conditions
- Resectable Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
- Being tested
- Samuraciclib, Computed Tomography, Endoscopic Ultrasound Biopsy, Biospecimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamuraciclibDrug
Also called CDK7 Inhibitor CT7001, CT 7001, CT-7001, CT7001
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Endoscopic Ultrasound BiopsyProcedure or surgery
Undergo EUS/FNB
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Samuraciclib; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound Biopsy; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 72 hours post versus pre-samuraciclib treatment
Secondary outcomes (6)
Incidence of samuraciclib-related adverse events
Will be measured by Common Terminology Criteria for Adverse Events version 6.
Measured: Within 30 days of the last dose of samuraciclib
Completion of 14 days of study drug (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Measured: Up to 90 days
Completion of the on-protocol research endoscopic ultrasound/fine needle biopsy (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Measured: Up to 90 days
Adequate biopsy (≥ 3 cores with ≥30% tumor cellularity) (Feasibility)
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Measured: 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)
Will be estimated using the Kaplan Meier method.
Measured: Up to 90 days
Incidence of schedule delays attributable to study drug
Will be summarized by proportions and 90% confidence intervals using the Wilson score method.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion14 Jul 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Lopker Family Foundation, Carrick Therapeutics Limited, The V Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Andrew Coveler, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645651
- Sponsor's protocol ID
- RG1126054
- Other IDs
- NCI-2026-01733, 21300
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No