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

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLei Zheng

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    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-682

    Drug

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Arm A - Tislelizumab and SX-682Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 2 weeks
2

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.

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years
2

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.

Time frame
4 years
3

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.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lei Zheng

Lead sponsor

The University of Texas Health Science Center at San Antonio

Sponsor institution

BeiGene

Collaborator

Syntrix Biosystems, Inc.

Collaborator

Source ClinicalTrials.gov
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