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A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer

A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer

Recruiting
18 years and older
All
Phase 2

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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.

Study details
    KRAS P.G12C
    Pancreatic Cancer

NCT06008288

Jacobio Pharmaceuticals Co., Ltd.

22 March 2024

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