Early Phase I Study of Targeted Pathway Drugs Including Cobimetinib, Olaparib, Onvansertib, Azenosertib, AZD5305, and Tremelimumab in Adults With Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating how several drugscobimetinib, olaparib, onvansertib, azenosertib, AZD5305 saruparib, and tremelimumabaffect patients with pancreatic cancer. This early phase I trial aims to understand changes in tumor biology after treatment and identify biomarkers that predict sensitivity or resistance to these agents. The results will support designing future studies to compare these targeted treatments against standard therapies for pancreatic cancer. Participants are assigned to one of six groups. Most receive an oral drug daily for 10 days, including azenosertib, AZD5305, cobimetinib, olaparib, or onvansertib, although the arms for olaparib, cobimetinib, and onvansertib are now closed. The tremelimumab group receives a single intravenous infusion. Within 12 to 24 hours after treatment, patients undergo a biopsy or surgery as appropriate. After treatment, patients are followed for 12 months to monitor outcomes. During the study, participants have biopsies before and after treatment to detect changes in tumor biology. Researchers assess safety, tolerability, and molecular changes in tumor cells. Blood tests and clinical evaluations are conducted to monitor health and side effects. The main goal is to measure tumor changes after treatment. Safety is monitored for up to 30 days, and patients are observed for one year following treatment completion.

Targeted Pathway Inhibition in Patients With Pancreatic Cancer