A Neoadjuvant Study Of Tislelizumab And SX-682 For Resectable Pancreas Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Tislelizumab
DRUG: SX-682

J2291
IRB00310755 (OTHER Identifier) (OTHER: Johns Hopkins Medical Institution)

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	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-13
First Submitted that Met QC Criteria 2022-10-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-15
First Posted (ACTUAL) 2022-11-03	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A - Tislelizumab and SX-682	DRUG: Tislelizumab 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 an DRUG: SX-682 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. Cycl

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A - Tislelizumab and SX-682

DRUG: Tislelizumab

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 an

DRUG: SX-682

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. Cycl

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Number of participants experiencing grade 3 or above drug-related toxicities	When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.	4 years
Overall Survival (OS)	OS is defined as the time from the first dose of study treatment to death from any cause. Patients who have not died will be censored at the last date known to be alive. Estimation based on the Kaplan-Meier curve.	4 years
Disease Free Survival (DFS)	DFS is defined as the time from the first dose of study treatment until evidence of disease recurrence or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, DFS will be censored on the date of last visit where disease progression was evaluable. Estimation based on the Kaplan-Meier curve.	4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Colleen Apostol, RN

Phone Number: 410-614-3644

Email: GIClinicalTrials@jhmi.edu

Study Contact Backup

Name: Joann Santmyer, RN

Phone Number: 410-614-3644

Email: GIClinicalTrials@jhmi.edu

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

BeiGene
Syntrix Biosystems, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Eric Christenson, MD, SKCCC Johns Hopkins Medical Institution

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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