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

Last updated: March 13, 2024
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Cancer

Pancreatitis

Treatment

Tislelizumab

SX-682

Clinical Study ID

NCT05604560
J2291
IRB00310755
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thepancreas.
  • 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-specifiedlaboratory tests.
  • For both Women and Men, must use acceptable form of birth control while on study.

Exclusion

Exclusion Criteria:

  • Have received any anti-pancreatic cancer therapy.
  • Have been diagnosed with another malignancy whose natural history or treatment has thepotential to interfere with safety or efficacy assessment of this study.
  • Conditions, including alcohol or drug dependence, intercurrent illness, or lack ofsufficient peripheral venous access, that would affect the patient's ability to complywith study visits and procedures
  • Subjects with active, known or suspected autoimmune disease that may relapse.
  • Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressivetherapy 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 uncontrolleddiseases including pulmonary fibrosis, acute lung diseases, etc.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolledinfection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heartfailure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatricillness/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 doseof 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 forthe length of the study.
  • ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QTsyndrome.
  • Severe hypersensitivity reaction to any monoclonal antibody.
  • Concurrent participation in another therapeutic clinical study
  • Pregnant or breastfeeding

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Tislelizumab
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Johns Hopkins SKCCC

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

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