Clinical trial NCT05604560: A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Official title: A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: BeiGene
name: Syntrix Biosystems, Inc.
First posted: 2022-11-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
timeFrame: Baseline and 2 weeks
measure: Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
timeFrame: 4 years
Secondary outcomes:
measure: Number of participants experiencing grade 3 or above drug-related toxicities
timeFrame: 4 years
measure: Overall Survival (OS)
timeFrame: 4 years
measure: Disease Free Survival (DFS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins SKCCC
state: Maryland
Study officials:
affiliation: SKCCC Johns Hopkins Medical Institution
name: Eric Christenson, MD
role: PRINCIPAL_INVESTIGATOR
References: