Overview
This study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult participants with KRAS G12C mutated pancreatic cancer
Description
This is a single-arm, open-label, multicenter phase 2 study to evaluate the efficacy and safety of JAB-21822 monotherapy in adult participants with advanced KRAS p.G12C mutated pancreatic cancer.
Eligibility
Inclusion Criteria:
- Histopathologically or cytologically confirmed pancreatic cancer with KRAS p.G12C mutation identified through molecular testing.
- Previously progressed on or after gemcitabine-based and/or FOFIRINOX/mFOFIRINOX chemotherapy, no more than 3 lines of prior systemic therapies. Participants with disease recurrence during or within 6 months after adjuvant therapy can be included.
- Participants with MSI-H/dMMR must experience anti-PD-1 therapy.
Exclusion Criteria:
- Previously received a KRAS G12C inhibitor.
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.).
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
- Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.
- Cannot discontinue a proton pump inhibitor (PPI) or H2 receptor blocker within 3 days or 5 half-lives (whichever is longer) prior to the first dose.