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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
1 Dec 2026to 1 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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.

Isabel Blanco contact

206-606-5864

giresearch@fredhutch.org

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Isabel Blanco, 206-606-5864, giresearch@fredhutch.org

    Andrew Coveler, MD

    Recruiting

Other trials in United States

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.

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 groups in NCT07645651
Study groupRoleWhat they receive
Treatment (Samuraciclib)ExperimentalPatients 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.

  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).

    Measured: Within 72 hours post versus pre-samuraciclib treatment

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted12 Jun 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion14 Jul 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

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)
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
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Isabel Blanco (206-606-5864, giresearch@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ribonucleic acid polymerase II serine levels (time frame: Within 72 hours post versus pre-samuraciclib treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07645651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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