Actively Recruiting
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Led by M.D. Anderson Cancer Center · Updated on 2026-01-20
50
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
C
Compass Therapeutics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
CONDITIONS
Official Title
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to understand and willingly sign informed consent
- Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancer not previously treated in the metastatic setting
- Measurable disease per RECIST v1.1 with at least one lesion measurable by imaging or clinical exam
- ECOG performance status 0 to 2
- Adequate organ and marrow function within 14 days before treatment, including specific blood counts and liver/kidney function
- No active infections; HBV must be controlled or suppressed, HCV treated and cured or undetectable
- Patients with prior or concurrent malignancies allowed if they do not interfere with study treatments
- Women of childbearing potential and men must agree to use effective contraception during and for 4 months after treatment
- Postmenopausal women or those with surgical sterilization are exempt from contraception requirements
You will not qualify if you...
- Previous treatment for the current malignancy in the metastatic setting (prior perioperative treatment allowed)
- History of active interstitial lung disease or certain lung conditions
- Major surgery within 28 days before treatment start (biliary stent procedures excluded)
- Presence of percutaneous transhepatic biliary drains
- Symptomatic or uncontrolled CNS metastasis (asymptomatic stable CNS metastases allowed)
- Active infections requiring systemic therapy except controlled HBV or HCV
- Known HIV positive status
- History of significant bleeding disorders or serious gastrointestinal diseases
- Active, uncontrolled autoimmune diseases requiring immunosuppressive treatment
- Active, uncontrolled inflammatory bowel disease
- Use of antiplatelet or anticoagulant drugs within 2 weeks before screening or expected need during the study
- Significant cardiovascular diseases within the past 5 years
- Significant vascular diseases within 6 months prior to treatment
- History of hypersensitivity to study drug components
- Use of other investigational agents
- Receipt of live attenuated vaccines within 30 days before or during the study
- Recent severe gastrointestinal bleeding
- Diagnosis of hepatic encephalopathy or malignant bowel obstruction
- Psychiatric or social conditions limiting compliance
- Pregnancy or breastfeeding due to potential risks of study treatments
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Ian Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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