NCT07665684
Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer
Not Yet Recruiting · Phase 1, Phase 2 · University Health Network, Toronto · registry updated 2026-06-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- 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.