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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

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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Disease Free Survival (DFS)

Number of participants experiencing grade 3 or above drug-related toxicities

Overall Survival (OS)

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

~4260

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

563 Previous Clinical Trials

33,299 Total Patients Enrolled

BeiGeneIndustry Sponsor

178 Previous Clinical Trials

28,895 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

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