A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

Korábbi kezelés

• Have received any anti-pancreatic cancer therapy.
• Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
• Prior allogeneic stem cell transplantation or organ transplantation
• Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
• Have received a live vaccine ≤ 28 days before first dose of study drug.
• Concurrent participation in another therapeutic clinical study

Más betegség

• Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.
• Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
• Subjects with active, known or suspected autoimmune disease that may relapse.
• Active infection requiring systemic therapy.
• Infection with HIV or hepatitis B or C at screening•
• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
• Severe hypersensitivity reaction to any monoclonal antibody.

Laborértékek

• Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.
• ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.

Egyéb

• Pregnant or breastfeeding

• Ability to understand and willingness to sign a written informed consent document.
• Age ≥18 years.
• Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.
• Tumor must be resectable.
• Patient's acceptance to have a tumor biopsy.
• ECOG performance status 0 or 1
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
• For both Women and Men, must use acceptable form of birth control while on study.