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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and clinical activity of tadalafil, pembrolizumab, ipilimumab, and CRS-207 in subjects with metastatic pancreatic adenocarcinoma who have progressed after at least 1 prior chemotherapy regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: BeiGene; Syntrix Biosystems, Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Have received any anti-pancreatic cancer therapy.

• 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.

• Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.

• Active infection requiring systemic therapy.

• Infection with HIV or hepatitis B or C at screening

• Uncontrolled diabetes or ≥ grade 2 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug.

• 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.

• 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.

• Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.

• Had chemotherapy, radiation, or biological cancer therapy within the last 14 days.

• Severe hypersensitivity reaction to any monoclonal antibody.

• Concurrent participation in another therapeutic clinical study

• Pregnant or breastfeeding