Last updated: March 13, 2024
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting
Phase
2
Condition
Pancreatic Cancer
Cancer
Pancreatitis
Treatment
Tislelizumab
SX-682
Clinical Study ID
NCT05604560
J2291
IRB00310755
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thepancreas.
- 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-specifiedlaboratory tests.
- For both Women and Men, must use acceptable form of birth control while on study.
Exclusion
Exclusion Criteria:
- Have received any anti-pancreatic cancer therapy.
- Have been diagnosed with another malignancy whose natural history or treatment has thepotential to interfere with safety or efficacy assessment of this study.
- Conditions, including alcohol or drug dependence, intercurrent illness, or lack ofsufficient peripheral venous access, that would affect the patient's ability to complywith study visits and procedures
- Subjects with active, known or suspected autoimmune disease that may relapse.
- Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressivetherapy 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 uncontrolleddiseases including pulmonary fibrosis, acute lung diseases, etc.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolledinfection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heartfailure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatricillness/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 doseof 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 forthe length of the study.
- ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QTsyndrome.
- Severe hypersensitivity reaction to any monoclonal antibody.
- Concurrent participation in another therapeutic clinical study
- Pregnant or breastfeeding
Study Design
Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Tislelizumab
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
September 30, 2026
Connect with a study center
Johns Hopkins SKCCC
Baltimore, Maryland 21231
United StatesActive - Recruiting
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