ClinicalTrials.Veeva

Menu

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

L

Lei Zheng

Status and phase

Active, not recruiting
Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: Tislelizumab
Drug: SX-682

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05604560
CTMS 24-0125
STUDY00001055

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Arm A - Tislelizumab and SX-682
Experimental group
Treatment:
Drug: SX-682
Drug: Tislelizumab

Trial contacts and locations

2

Loading...

Central trial contact

Colleen Apostol, RN; Joann Santmyer, RN

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems