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

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

NCT ID: NCT05604560

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms
Tislelizumab

Conditions: 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

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tislelizumab
Description: 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.
Arm group label: Arm A - Tislelizumab and SX-682

Other name: BGB-A317

Intervention type: Drug
Intervention name: SX-682
Description: 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 group label: Arm A - Tislelizumab and SX-682

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Johns Hopkins SKCCC

Address:
City: Baltimore
Zip: 21231
Country: United States

Status: Recruiting

Contact:
Last name: Colleen Apostol, RN

Phone: 410-614-3644
Email: GIClinicalTrials@jhmi.edu

Contact backup:
Last name: Joann Santmyer, RN

Phone: 410-614-3644
Email: GIClinicalTrials@jhmi.edu

Investigator:
Last name: Eric Christenson, MD
Email: Principal Investigator

Start date: November 8, 2023

Completion date: September 2026

Lead sponsor:
Agency: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class: Other

Collaborator:
Agency: BeiGene
Agency class: Industry

Collaborator:
Agency: Syntrix Biosystems, Inc.
Agency class: Industry

Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05604560