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Monoclonal Antibodies

Tislelizumab + SX-682 for Pancreatic Cancer

Phase 2
Recruiting
Led By Eric Christenson, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Newly diagnosed with histologically or cytologically proven adenocarcinoma of the pancreas
Must not have
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc
Infection with HIV or hepatitis B or C at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a combo of drugs to see if they're safe & effective for advanced pancreatic cancer after other treatments have failed.

Who is the study for?
Adults over 18 with newly diagnosed, resectable pancreatic adenocarcinoma can join this trial. They must understand and consent to the study, have good performance status (ECOG 0 or 1), adequate organ function, agree to use birth control, and be willing to undergo a tumor biopsy.
What is being tested?
The trial is testing the safety and effectiveness of Tislelizumab combined with SX-682 in patients who've had prior chemotherapy for metastatic pancreatic cancer. It aims to see how well these drugs work before surgery (neoadjuvant therapy).
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies like Tislelizumab, increased risk of infection due to immune system suppression, possible heart rhythm problems (QTc interval changes), lung issues such as pneumonitis or fibrosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been recently diagnosed with pancreatic cancer.
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I am fully active or can carry out light work.
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I agree to have a tumor biopsy.
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My tumor can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of lung conditions like interstitial lung disease or pulmonary fibrosis.
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I do not have HIV or hepatitis B or C.
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I have had a stem cell or organ transplant in the past.
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I haven't taken any drugs that affect my heart's rhythm in the last 2 weeks.
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I have received treatment for pancreatic cancer.
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I have another cancer that could affect this study's safety or results.
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I am currently on medication for an infection.
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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
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I do not have any severe illnesses that my doctors are still trying to get under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
Secondary study objectives
Disease Free Survival (DFS)
Number of participants experiencing grade 3 or above drug-related toxicities
Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm A - Tislelizumab and SX-682Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SX-682
2020
Completed Phase 2
~20
Tislelizumab
2018
Completed Phase 3
~4700

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,205 Total Patients Enrolled
BeiGeneIndustry Sponsor
198 Previous Clinical Trials
30,767 Total Patients Enrolled
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
782 Total Patients Enrolled

Media Library

Tislelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05604560 — Phase 2
Pancreatic Cancer Research Study Groups: Arm A - Tislelizumab and SX-682
Pancreatic Cancer Clinical Trial 2023: Tislelizumab Highlights & Side Effects. Trial Name: NCT05604560 — Phase 2
Tislelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604560 — Phase 2
~16 spots leftby Sep 2026
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