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

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.

Conditions

Pancreatic Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins SKCCC, Baltimore, Maryland, United States, 21231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Eric Christenson, MD, PRINCIPAL_INVESTIGATOR, SKCCC Johns Hopkins Medical Institution

Study Record Dates

2026-09