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A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Testing Setidegrasib with chemotherapy for pancreatic cancer safety and effectiveness.

Recruiting
18 years and older
All
Phase 3
**Study Purpose:** The study looks at using a new drug, setidegrasib, with chemotherapy to treat pancreatic cancer. Pancreatic cancer is hard to find early and often spreads (metastatic) before being diagnosed, making it hard to treat. Chemotherapy is a common treatment, but this study tests if adding setidegrasib helps people live longer and delays cancer returning. It focuses on patients with a specific gene change (KRAS G12D mutation) in their cancer. **Important Study Details:** - **Who Can Join:** Adults with pancreatic cancer that has spread and have the KRAS G12D mutation. Surgery or radiation isn't an option for them. - **Treatment:** Participants may get setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with one of these chemotherapies. Treatment continues until cancer worsens or other specified conditions occur. - **Exclusions:** Participants can't join if they have cancer in the brain, other recent cancers needing treatment, or certain health problems like severe bowel disease. This study helps understand if setidegrasib is a safe and effective treatment option for pancreatic cancer.
Study details
    Pancreatic Cancer
    Metastatic Pancreatic Cancer
    Metastatic Pancreatic Adenocarcinoma

NCT07409272

Astellas Pharma Global Development, Inc.

11 October 2026

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