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

NCT ID: NCT05604560

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2026-09-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A - Tislelizumab and SX-682

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: 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

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

BGB-A317

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: collaborator

Syntrix Biosystems, Inc.

INDUSTRY

Sponsor Role: collaborator

Lei Zheng

OTHER

Sponsor Role: lead

Responsible Party

Lei Zheng

Executive Director of University of Texas Health Science Center at San Antonio Cancer Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lei Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Johns Hopkins SKCCC

Baltimore, Maryland, United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

STUDY00001055

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS 24-0125

Identifier Type: -

Identifier Source: org_study_id