Pancreas Ductal AdenocarcinomaPhase 1/2SONICNCT07665684
Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer
A Phase 1/2 study testing Samuraciclib + Gemcitabine & Nab-Paclitaxel in people with Pancreas Ductal Adenocarcinoma and Pancreas Cancer, Metastatic, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Ductal Adenocarcinoma, Pancreas Cancer, Metastatic, Pancreatic Adenocarcinoma Metastatic
- What is being tested?
- Samuraciclib + Gemcitabine & Nab-Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2026to May 2030
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization (eg, data privacy) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.
- Must have life expectancy ≥ 12 weeks at the time of screening.
- Histologically or cytologically confirmed PDAC: Eligible histological variants include: mucinous adenocarcinoma, independent cell adenocarcinoma, adenosquamous carcinoma, adenocarcinoma not otherwise specified (NOS).
- Dose Escalation: All patients with metastatic PDAC will be permitted to enrol.
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- Dose Expansion: Patients with metastatic basal-like PDAC will be permitted to enrol, based on the PurIST assay or by transcriptomic sequencing. Patients will be permitted to start no more than one cycle of gemcitabine/nab-paclitaxel while waiting for transcriptional subtype results in the dose expansion cohort.
- Radiographic evidence of metastatic disease that is measurable per RECIST 1.1.
- Adequate organ and marrow function within 28 days prior to dosing on Day 1.
- Adequate liver function (AST ≤2.5 times the institutional upper limit of normal, total bilirubin ≤2 times the institutional upper limit of normal) at the baseline visit. Patients are permitted to enroll with biliary obstruction, as long as they undergo appropriate biliary decompression (can be done at the same time as endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB)) and hepatic parameters have improved at time of baseline visit.
- Patients must have either de novo metastatic disease or recurrence >6 months after completion of neoadjuvant or adjuvant intent systemic therapy.
- Patients must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments at the time of enrollment (excluding neuropathy which can be ≤ Grade 2, and alopecia)
- Patients must be able to take oral medications.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study treatment. It is strongly recommended for the male partner of a female patient to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male patient to also use a highly effective method of contraception throughout this period. In addition, male patients must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.
Who cannot join
- Participants receiving any other study agents concurrently with the study drugs.
- Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1/2 or PALB2 mutations
- Concurrent enrolment in another therapeutic clinical study. Enrolment in observational or supportive care studies will be allowed.
- History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.
- Patients with a history of Grade 3 or greater thromboembolic events in the prior 3 months to the scheduled first dose of study treatment or thromboembolic event of any grade with ongoing symptoms.
- Patients with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.
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- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- Other invasive malignancy within 2 years. Non-invasive malignancies (ie, cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study treatment and of low potential risk for recurrence are permitted.
- Known allergy or hypersensitivity to investigational product formulations.
- Active grade 3 or greater edema (eg, peripheral, pulmonary).
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Participants with known untreated brain metastases are excluded. Patients with a history of brain metastases are permitted to enroll if they have been treated and have been stable for a minimum of one month on imaging. Participants must be off all corticosteroids at the time of enrolment.
- Major surgery (as defined by the investigator) within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local procedures (eg, placement of a systemic port, core needle biopsy, etc) are allowed, without needing to wait for the 28 day recovery period.
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.
- Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of patient safety or study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Anna Dodd, 647-539-6498, Anna.Dodd@uhn.ca
Erica Tsang, MD
About this study
Official title: Phase Ib/II Study of Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer
The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:
- For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine/nab-paclitaxel?
Read more
Participants will:
- Undergo a tumor biopsy.
- Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine/nab-paclitaxel).
- Donate research blood samples.
- Conditions
- Pancreas Ductal Adenocarcinoma, Pancreas Cancer, Metastatic, Pancreatic Adenocarcinoma Metastatic, Adenosquamous Carcinoma of the Pancreas, Mucinous Adenocarcinoma
- Being tested
- Samuraciclib + Gemcitabine & Nab-Paclitaxel
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samuraciclib + Gemcitabine & Nab-PaclitaxelDrug
Starting dose level:
Samuraciclib 240 mg taken orally, once daily. Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.
| Study group | Role | What they receive |
|---|---|---|
| Samuraciclib + GnP | Experimental | Samuraciclib + Standard of Care Chemotherapy (Gemcitabine \& Nab-Paclitaxel) Receives: Drug: Samuraciclib + Gemcitabine & Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Percentages of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Frequencies of dose-limiting toxicities reported by dose level
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Percentages of dose-limiting toxicities reported by dose level
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Maximum tolerated dose, defined as the highest dose level where a dose-limiting toxicity occurs within at most one out of six patients treated
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Recommended phase II dose (RP2D)
The RP2D will be selected based on the evaluation of dose-limiting toxicities and adverse events measured using CTCAE v6.0.
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Secondary outcomes (4)
Objective response rate (ORR)
Defined as the proportion of participants who achieve a Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 best overall response of confirmed complete response (CR) or confirmed partial response (PR)
Measured: From date of enrollment to date off treatment, assessed up to 24 months
Progression-free survival (PFS)
Defined as the duration of time from start of treatment to time of disease recurrence/progression (PD) or death from any cause, whichever occurs first.
Measured: From date of enrollment to date of first progression or death, assessed up to 24 months
Overall survival (OS)
Defined as the duration of time from time of diagnosis to death.
Measured: From date of enrollment to date of death, assessed up to 24 months
Duration of overall response (DOR)
Defined as the duration of time from when measurement criteria are met for CR or PR (whichever is first recorded) until the date that recurrent/progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started).
Measured: From date of enrollment to date of first progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665684
- Sponsor's protocol ID
- OZUHN-049
- Acronym
- SONIC
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07665684
- Acronym / sponsor ID
- SONIC / OZUHN-049
- Conditions
- Pancreas Ductal Adenocarcinoma, Pancreas Cancer, Metastatic, Pancreatic Adenocarcinoma Metastatic, Adenosquamous Carcinoma of the Pancreas, Mucinous Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:
- For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine/nab-paclitaxel?
Participants will:
- Undergo a tumor biopsy.
- Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine/nab-paclitaxel).
- Donate research blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samuraciclib + GnP | Experimental | Drug: Samuraciclib + Gemcitabine & Nab-PaclitaxelSamuraciclib + Standard of Care Chemotherapy (Gemcitabine \& Nab-Paclitaxel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization (eg, data privacy) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.
- Must have life expectancy ≥ 12 weeks at the time of screening.
- Histologically or cytologically confirmed PDAC: Eligible histological variants include: mucinous adenocarcinoma, independent cell adenocarcinoma, adenosquamous carcinoma, adenocarcinoma not otherwise specified (NOS).
Key exclusion criteria (16 listed)
- Participants receiving any other study agents concurrently with the study drugs.
- Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1/2 or PALB2 mutations
- Concurrent enrolment in another therapeutic clinical study. Enrolment in observational or supportive care studies will be allowed.
- History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.
- Patients with a history of Grade 3 or greater thromboembolic events in the prior 3 months to the scheduled first dose of study treatment or thromboembolic event of any grade with ongoing symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samuraciclib + Gemcitabine & Nab-PaclitaxelStarting dose level: Samuraciclib 240 mg taken orally, once daily. Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15. | Drug | Samuraciclib + GnP |
Primary outcome
Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Percentages of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Frequencies of dose-limiting toxicities reported by dose level
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Percentages of dose-limiting toxicities reported by dose level
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Maximum tolerated dose, defined as the highest dose level where a dose-limiting toxicity occurs within at most one out of six patients treated
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Recommended phase II dose (RP2D)
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
The RP2D will be selected based on the evaluation of dose-limiting toxicities and adverse events measured using CTCAE v6.0.
4 secondary outcomes
Objective response rate (ORR)
Time frame: From date of enrollment to date off treatment, assessed up to 24 months
Progression-free survival (PFS)
Time frame: From date of enrollment to date of first progression or death, assessed up to 24 months
Overall survival (OS)
Time frame: From date of enrollment to date of death, assessed up to 24 months
Duration of overall response (DOR)
Time frame: From date of enrollment to date of first progression, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Samuraciclib + Gemcitabine & Nab-Paclitaxel in people with Pancreas Ductal Adenocarcinoma and Pancreas Cancer, Metastatic, run by University Health Network, Toronto at 1 site in Canada.
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 15 inclusion and 16 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: opening soon, as of the sponsor's last update on 24 Jun 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 Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Erica Tsang, MD (4169462000, Erica.Tsang@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level (time frame: From date of enrollment to date off treatment, assessed up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.