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

NCT05604560 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CTMS 24-0125STUDY00001055
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (2)

• Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells

  The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.

  Baseline and 2 weeks

• Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response

  The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.

  4 years

Secondary Outcomes (3)

• Number of participants experiencing grade 3 or above drug-related toxicities

  4 years

• Overall Survival (OS)

  4 years

• Disease Free Survival (DFS)

  4 years

Study Arms (1)

Arm A - Tislelizumab and SX-682

EXPERIMENTAL

Drug: Tislelizumab; Drug: SX-682

Interventions

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.

Also known as: BGB-A317

Arm A - Tislelizumab and SX-682

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.

Arm A - Tislelizumab and SX-682

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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.

Sponsors & Collaborators

• Lei Zheng: lead
• BeiGene: collaborator
• Syntrix Biosystems, Inc.: collaborator

Study Sites (2)

Johns Hopkins SKCCC

Baltimore, Maryland, 21231, United States

Location

The University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Lei Zheng, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director of University of Texas Health Science Center at San Antonio Cancer Center

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: November 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)