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Recruiting
NCT05604560
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Conditions: Pancreatic Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 25
Sponsor: Lei Zheng
Location: Johns Hopkins SKCCC Baltimore Maryland
Summary
The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.
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
Source: ClinicalTrials.gov (NCT05604560). StuddyBuddy aggregates publicly available trial information.