NCT05604560 · Lei Zheng
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Tislelizumab
Patients will receive Tislelizumab (200 mg intravenous) on Day 1 of Cycles 1-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy.
DRUG
SX-682
Patients will receive SX-682 (200 mg twice daily by mouth) on Days 1-14 of Cycles 1-2 and Days 1-21 of Cycles 3-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy.
Primary outcome measures
Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
Time frame: Baseline and 2 weeks
The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.
Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
Time frame: 4 years
The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
- San Antonio, Texas
Collaborators
BeiGene, Syntrix Biosystems, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations