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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment25 people
  • Recruiting US sites1
  • SponsorLei Zheng
  • RegistryNCT05604560

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer: a one-minute explainerNCT056045601 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

tislelizumab-jsgr. A monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, tislelizumab-jsgr binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells. PD-1, a transmembrane protein in the immunoglobulin (Ig) superfamily expressed on activated T cells, negatively regulates T-cell activation and effector function when activated by its ligands; it plays an important role in tumor evasion from host immunity. NCI Drug Dictionary

Cxcr1/2 inhibitor SX-682. An orally bioavailable, selective and reversible antagonist of C-X-C motif chemokine receptors 1 (CXCR1) and 2 (CXCR2), with potential anti-inflammatory and antineoplastic activities. Upon administration CXCR1/2 inhibitor SX-682 selectively and allosterically binds to CXCR 1 and 2 and inhibits their activation by tumor-secreted chemokines. This inhibits CXCR1/2-mediated signaling, reduces both recruitment and migration of immunosuppressive myeloid-derived suppressor cells (MDSCs) and neutrophils in the tumor microenvironment (TME), inhibits inflammatory processes and abrogates the immunosuppressive-induced nature of the TME. This allows effector cells, such as natural killer (NK) cells and cytotoxic T lymphocytes (CTLs), to kill and eliminate cancer cells. This inhibits tumor cell migration, metastasis, angiogenesis and tumor cell proliferation. CXCR1 and 2, G protein-coupled receptor proteins located on myeloid cells and certain tumor cells, play key roles in the immunosuppressive nature of the TME, tumor metastasis, therapy-resistance and myeloid cell suppression. They play a key role in inflammation and their expression is elevated in several inflammatory-driven diseases. NCI Drug Dictionary

Treatments listed in the registry

  • Tislelizumab (Drug): 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.
  • SX-682 (Drug): 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.

The study

Treatment groups

Na · Single Group · masking: None

Arm A - Tislelizumab and SX-682 (Experimental)

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan

Goals

What the study measures

Main goals

  • Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells (Baseline and 2 weeks)
  • Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response (4 years)

Other goals

  • Number of participants experiencing grade 3 or above drug-related toxicities
  • Overall Survival (OS)
  • Disease Free Survival (DFS)

Planned enrollment: 25 (estimated).

Where

Recruiting US sites

  • The University of Texas Health Science Center San Antonio, San Antonio, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 6, 2026. Public record; not medical advice.

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