Actively Recruiting
Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Led by Washington University School of Medicine · Updated on 2026-04-03
48
Participants Needed
1
Research Sites
322 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Curis, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor microenvironment (TME) to render chemo- and immunotherapies effective in GI malignancy. Therefore, this trial is designed to evaluate the combination of emavusertib (CA-4948) and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer (BTC).
CONDITIONS
Official Title
Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced unresectable or metastatic adenocarcinoma of the biliary tract confirmed by tissue diagnosis
- Measurable disease according to RECIST v1.1 criteria
- No prior systemic treatment for advanced unresectable or metastatic biliary tract cancer, except neoadjuvant or adjuvant therapy completed more than 6 months before study start
- Up to two prior cycles of gemcitabine/cisplatin/anti-PD1 allowed if no disease progression
- At least 18 years old
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow and organ function including neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, creatinine clearance, and coagulation parameters
- Creatinine phosphokinase elevation less than Grade 2 at screening
- Stable dose of cholesterol-lowering statins for at least 3 weeks prior to study
- Women of childbearing potential and men must agree to use effective contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Use or anticipated need for alternative or botanical cancer treatments (medical marijuana permitted)
- History of other malignancies unless treated and disease-free for at least 2 years or indolent malignancies not affecting BTC treatment
- History of allogeneic organ or stem cell transplant
- Current use of other investigational therapies (except imaging tracers with washout)
- Active central nervous system metastases (treated and stable allowed)
- Recent chemoradiation or palliative radiation therapy within specified timeframes
- Allergic reactions to study drugs or similar compounds
- Use of drugs causing prolonged QTc or history of Torsades de Pointes
- Interstitial lung disease or pneumonitis Grade 2 or higher at screening
- Live attenuated vaccine within 30 days prior to treatment
- QTc >470ms on screening ECG
- Gastrointestinal conditions impairing drug absorption
- Uncontrolled illnesses such as active infections or unstable heart conditions
- Pregnancy or breastfeeding; women must have a negative pregnancy test
- HIV patients with low CD4 counts or recent AIDS-defining infections
- Active or suspected autoimmune diseases except certain stable conditions after discussion
- Recent use of systemic corticosteroids or immunosuppressive drugs except specified exceptions
- History of severe rhabdomyolysis unresolved
- Unwillingness to follow lifestyle guidance during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
O
Olivia Aranha, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here