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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
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
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,895 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,789 Total Patients Enrolled
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
782 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for an infection.I have a history of lung conditions like interstitial lung disease or pulmonary fibrosis.I do not have HIV or hepatitis B or C.I have an autoimmune disease that might get worse.I have had a stem cell or organ transplant in the past.I haven't taken any drugs that affect my heart's rhythm in the last 2 weeks.I have received treatment for pancreatic cancer.You have had a strong allergic reaction to any monoclonal antibody.I am 18 years old or older.I am fully active or can carry out light work.I do not have any severe illnesses that my doctors are still trying to get under control.I am using or willing to use birth control during the study.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have not received a live vaccine in the last 4 weeks.I do not have any health issues or substance dependencies that would prevent me from following the study's requirements.I have another cancer that could affect this study's safety or results.I have been recently diagnosed with pancreatic cancer.My organ and bone marrow functions meet the required levels.I haven't had major surgery with general anesthesia in the last 28 days.I agree to have a tumor biopsy.Your heart test shows a specific kind of electrical activity that could be risky for the study.My tumor can be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Tislelizumab and SX-682
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project have any unfilled appointments?
"No, this particular medical trial is not currently seeking new patients. That being said, there are 726 other clinical trials that are actively recruiting people right now."
Answered by AI
What are the FDA's thoughts on Arm A - Tislelizumab and SX-682?
"Arm A - Tislelizumab and SX-682 is currently being trialed in Phase 2. While there is evidence that this intervention is safe, its efficacy has not yet been studied."
Answered by AI
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