Study on CTX-009 with Gemcitabine, Cisplatin, and Durvalumab for First-line Treatment in Patients with Advanced Biliary Tract Cancers
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06548412
This clinical trial is testing a new combination of drugs, including CTX-009, with standard chemotherapy and immunotherapy to see if it can be a safe and effective first treatment for patients with advanced biliary tract cancers that cannot be removed by surgery.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if adding the drug CTX-009 to the standard treatment of gemcitabine, cisplatin, and durvalumab can be a safe and effective first-line therapy for patients with advanced biliary tract cancers that cannot be surgically removed or have spread to other parts of the body.
Description
The main goals of this study are to determine how well patients tolerate the combination of CTX-009 with standard chemotherapy and immunotherapy, and to find the highest dose of CTX-009 that can be given safely. Researchers will also look at how long patients live without their cancer getting worse, how many patients respond to the treatment, how long those responses last, and overall survival rates.
Participants must be at least 18 years old and have advanced biliary tract cancer that has not been treated in the metastatic setting. They must have measurable disease and be in good overall health. Women and men must agree to use effective birth control during the study and for four months after the last dose of CTX-009.
Patients cannot participate if they have had previous treatment for their current cancer, have certain lung diseases, or have had major surgery recently. Other exclusions include having active infections, certain heart conditions, or being pregnant or breastfeeding. Participants must not have received certain medications or vaccines recently, and they must not have other serious health conditions that could interfere with the study.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must understand and agree to sign a consent form.
- Must have advanced biliary tract cancer that cannot be removed by surgery and has not been treated in the metastatic setting.
- Must have measurable cancer that can be tracked by scans or exams.
- Must be in good overall health with a performance status of 0 to 2.
- Must have adequate organ and bone marrow function based on specific blood tests.
- Must not have any active infections.
- Must agree to use effective birth control during the study and for four months after the last dose of CTX-009.
Exclusion Criteria
- Previous treatment for the current cancer.
- Certain lung diseases or conditions affecting the lungs.
- Major surgery within the last 28 days.
- Active or uncontrolled brain cancer.
- Active infections requiring treatment, except for controlled hepatitis B or C.
- Positive for HIV.
- History of significant bleeding or gastrointestinal diseases.
- Uncontrolled autoimmune diseases.
- Recent use of certain blood-thinning medications.
- Certain heart conditions within the last five years.
- Significant vascular diseases within the last six months.
- Allergies to study drugs or similar medications.
- Participation in another clinical trial or use of investigational drugs.
- Recent live vaccinations.
- Recent severe gastrointestinal bleeding.
- Diagnosis of hepatic encephalopathy.
- History of bowel obstruction.
- Psychiatric or social issues that could affect participation.
- Pregnant or breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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