Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Lik… (NCT07665684) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer
Canada67 participantsStarted 2026-07
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Dose Escalation: All patients with metastatic PDAC will be permitted to enrol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
2
Percentages of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
3
Frequencies of dose-limiting toxicities reported by dose level
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
4
Percentages of dose-limiting toxicities reported by dose level
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
5
Maximum tolerated dose, defined as the highest dose level where a dose-limiting toxicity occurs within at most one out of six patients treated
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
6
Recommended phase II dose (RP2D)
Timeframe: From date of enrollment to date off treatment, assessed up to 24 months
. 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.
Exclusion criteria
. 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.
. 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).