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.
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.
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.