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NCT05604560 | RECRUITING | Pancreatic Cancer

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Condition or disease

Pancreatic Cancer

Intervention/treatment

Tislelizumab

SX-682

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Actual Study Start Date : 2023-11-08
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

Location Details

NCT05604560

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Locations

RECRUITING

United States, Maryland

Johns Hopkins SKCCC

Baltimore, Maryland, United States, 21231