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ACTIVE NOT RECRUITING

NCT05604560

PHASE2

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

Sponsor: Lei Zheng

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-11-08

Completion Date

2026-09

Last Updated

2025-07-23

Healthy Volunteers

Conditions

Pancreatic Cancer

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.

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

Locations (2)

Johns Hopkins SKCCC

Baltimore, Maryland, United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas, United States