Combining Tislelizumab and SX-682 for Treating Resectable Pancreatic Cancer
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
This study is testing if combining two treatments, tislelizumab and SX-682, can help shrink tumors in patients with newly diagnosed pancreatic cancer before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | prednisone, tislelizumab |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05604560 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of tislelizumab, an anti-PD-1 antibody, in combination with SX-682, a CXCR1/2 inhibitor, for patients with newly diagnosed and surgically resectable pancreatic adenocarcinoma. Participants will undergo treatment before surgery to assess how well the combination works in shrinking tumors and improving surgical outcomes. The study aims to gather data on the clinical activity of this combination therapy in a Phase 2 setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed resectable pancreatic adenocarcinoma.
Not a fit: Patients who have received prior anti-pancreatic cancer therapy or have other malignancies that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival rates for patients with resectable pancreatic cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in pancreatic cancer, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins SKCCC — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Eric Christenson, MD — SKCCC Johns Hopkins Medical Institution
- Study coordinator: Colleen Apostol, RN
- Email: GIClinicalTrials@jhmi.edu
- Phone: 410-614-3644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.