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

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Oct 28, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with resectable pancreatic cancer, which means their tumors can be surgically removed. The study is testing a combination of two drugs: tislelizumab, which helps the immune system fight cancer, and SX-682, which targets specific pathways that tumors use to grow. The goal is to see how safe this combination is and how well it works in treating pancreatic cancer.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of pancreatic adenocarcinoma that can be surgically removed. You will also need to be healthy enough to undergo the required procedures and willing to provide a biopsy of your tumor. Participants can expect regular visits for treatments and tests throughout the study, and both men and women must use birth control during this time. If you have other serious health conditions or have received previous cancer treatments, you may not qualify for this trial. Overall, this study aims to explore a promising new treatment for pancreatic cancer and could be a valuable opportunity for eligible patients.

Gender

ALL

Eligibility 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•
• • 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.
• • ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.
• • Severe hypersensitivity reaction to any monoclonal antibody.
• • Concurrent participation in another therapeutic clinical study
• • Pregnant or breastfeeding