ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-08

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05604560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Lei Zheng, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

Johns Hopkins SKCCC

Baltimore, Maryland, 21231

United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Lei Zheng

Lei Zheng, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Pancreatic Cancer