drugset / Trial / NCT07665684

Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer

NCT07665684

Phase 1/2 Not yet recruiting 67 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-07
Primary completion
2029-05
Completion
2030-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Samuraciclib Unknown 240 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2
Background Paclitaxel Small molecule 125 mg/m2