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CTX-009 + Standard Treatment for Biliary Tract Cancer
Phase 1 & 2
Waitlist Available
Led By Ian Hu, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
ECOG performance status ≤2
Must not have
History of hemorrhage-related or gastroenterological disease
Active, uncontrolled inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if adding CTX-009 to the standard treatment GCD can be helpful as the first treatment for patients with inoperable or advanced bile duct cancer.
Who is the study for?
This trial is for patients with biliary tract cancers that cannot be removed by surgery or have spread. Participants must meet certain health standards, which are not specified here.
What is being tested?
The study tests a new treatment combo: CTX-009 plus standard drugs Gemcitabine and Cisplatin, along with Durvalumab, to see if it's better as a first-line therapy for these cancer patients.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to Durvalumab, kidney issues from Cisplatin, and blood cell count changes from Gemcitabine.
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 can take care of myself but might not be able to do heavy physical work.
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My bile duct cancer cannot be removed by surgery and has spread or come back.
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I do not have any current infections.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of bleeding disorders or stomach/intestinal diseases.
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I have an ongoing, untreated inflammatory bowel condition.
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I have had heart disease within the last 5 years.
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I have been treated for my current cancer before.
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I have been diagnosed with hepatic encephalopathy.
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I have had active lung disease affecting the tissue and space around the air sacs of my lungs.
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I have a history of lung scarring or inflammation not caused by infections.
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I have not had major surgery in the last 28 days.
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My brain metastasis is causing symptoms or is not under control.
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I have an autoimmune disease that is not under control.
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I have had a blockage in my intestines caused by cancer.
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I have had severe GI bleeding in the last 3 months.
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I do not have any active infections needing treatment, except for HBV or HCV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Adverse Events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions
Participants will be administered treatment on an outpatient basis
Group II: Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions
Participants will be administered treatment on an outpatient basis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Cisplatin
2013
Completed Phase 3
~3120
Durvalumab
2017
Completed Phase 2
~3750
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,758 Total Patients Enrolled
Compass Therapeutics, IncUNKNOWN
Ian Hu, MDPrincipal InvestigatorM.D. Anderson Cancer Center