Phase 2 Study of Pimicotinib ABSK021 with Chemotherapy, With or Without Toripalimab, in Adults With Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Pimicotinib ABSK021 combined with chemotherapy, with or without the addition of Toripalimab, in patients with advanced pancreatic cancer. This phase II, open-label study aims to understand how well this combination works and how safe it is for people with non-resectable local advanced or metastatic pancreatic cancer. The study is sponsored by Abbisko Therapeutics Co, Ltd and focuses on patients who have not received prior systemic treatment for pancreatic cancer. Participants receive Pimicotinib orally once daily along with chemotherapy drugs Gemcitabine and nab-Paclitaxel given by intravenous infusion on days 1 and 8 of each 21-day cycle. In one group, Toripalimab is also given intravenously on day 1 of each cycle. Treatment lasts about 24 weeks, covering approximately eight cycles. The study includes two cohorts in both parts A and B to compare the combination with and without Toripalimab. During the study, participants undergo assessments to monitor safety events from the day they consent until 90 days after completing eight cycles, as well as evaluations of tumor response. Researchers also track the duration of response, progression-free survival, overall survival, and drug levels in the blood during the treatment period. Participants complete all study procedures as outlined by the researchers, who guide them through the process to evaluate the treatments effects over time.

A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer