Recruiting
Phase 2

Tislelizumab & SX-682

Sponsor:

Lei Zheng

Code:

NCT05604560

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tislelizumab

SX-682

Study Details

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.

Conditions

Pancreatic Cancer

Study ID

NCT05604560

Start date

Nov 8, 2023

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A - Tislelizumab and SX-682

Interventions

Tislelizumab

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Epp Goodwin

210-450-5798goodwine@uthscsa.edu

Lei Zheng, MD

zhengl@uthscsa.edu

Locations

The University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Epp Goodwin

210-450-5798goodwine@uthscsa.edu

Principal Investigator:

Lei Zheng, MD

More Information

Sponsor

Lei Zheng

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • Pancreatic cancer
  • Adenocarcinoma
  • Resectable pancreas cancer
  • Tislelizumab
  • Anti-PD-1
  • PD-L1
  • Antibody
  • SX-682
  • CXCR1/2 (chemokine receptor)
  • CXCR1/2 inhibitor
  • Small molecule
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Lei Zheng on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.