Pancreatic CancerPhase 2NCT05604560
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
A Phase 2 study testing Tislelizumab and SX-682 in people with Pancreatic Cancer, run by Lei Zheng at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Tislelizumab and SX-682
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2023to Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Zheng, MD contact
United States2 sites, 1 recruiting
- Completed
Johns Hopkins SKCCC
Baltimore, Maryland, 21231
- Recruiting
The University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Epp Goodwin, 210-450-5798, goodwine@uthscsa.edu
Lei Zheng, MD
About this study
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Tislelizumab, SX-682
- 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
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
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.
SX-682Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Tislelizumab and SX-682 | Experimental | Not described Receives: Drug: Tislelizumab; Drug: SX-682 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start8 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene, Syntrix Biosystems, Inc.
- Responsible party
- Sponsor-investigator, Lei Zheng, The University of Texas Health Science Center at San Antonio
- Investigators
- Lei Zheng, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604560
- Sponsor's protocol ID
- CTMS 24-0125
- Other IDs
- STUDY00001055
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No