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

Johns Hopkins Medicine

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: Tislelizumab

Drug: SX-682

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05604560

IRB00310755 (Other Identifier)

J2291

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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