Actively Recruiting
A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Led by National Cancer Institute (NCI) · Updated on 2026-03-24
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Biliary tract carcinoma (BTC) is a cancer affecting the thin tubes that carry fluids in the liver, and advanced BTC has very limited treatment options with low survival rates. This research aims to study the combination of a drug called CDX-1140 with three other drugs—capecitabine, oxaliplatin, and Keytruda—in adults with BTC that has progressed after treatment and is not suitable for surgery or liver transplant. The trial is a Phase I/II, non-randomized study focusing on safety and effectiveness measures such as progression-free survival and response rate. Participants will receive treatment in 21-day cycles for up to 6 cycles. Oxaliplatin will be given intravenously on day 1 of each cycle, capecitabine is taken orally twice daily for the first two weeks of each cycle, and Keytruda along with CDX-1140 will be administered intravenously on day 8 of each cycle. After 6 cycles, intravenous treatments continue only on day 1, and participants may continue the study treatment for up to 2 years. Imaging scans will be done every 9 weeks to monitor disease status. During the study, participants will undergo screening with physical exams, blood tests, heart function tests, imaging scans, and possibly tumor biopsies. Researchers will regularly assess safety, disease progression, and response using established criteria. Follow-up visits and imaging will continue for 3 years after treatment ends, with images possibly taken at other locations and sent to the study team. Total participation may last several years, allowing close monitoring and evaluation of participant outcomes.
CONDITIONS
Brief Title
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of biliary tract carcinoma (BTC) or carcinoma with clinical and radiological features strongly suggesting BTC
- Maximum tumor size of any tumor or metastasis is 8 cm or less
- Disease has progressed after first-line systemic treatment or patient refused standard treatment
- Disease is not suitable for potentially curative surgery or liver transplantation
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function including specific blood counts and liver/kidney function thresholds
- Age 18 years or older
- Recovered from any acute toxicity related to prior therapy to grade 1 or less
- Agree to use adequate contraception during and after the study treatment as defined
- Nursing participants must agree to stop nursing during and after study treatment
- For hepatitis B or C, must be on treatment or have undetectable viral levels
- Ability to understand and sign informed consent
You will not qualify if you...
- Anti-cancer therapy or investigational agents within 4 weeks prior to study treatment
- Prior treatment with anti-CD40 agents
- Live vaccines within 30 days before treatment start (except killed virus vaccines like injectable flu vaccine)
- Major surgery within 4 weeks before treatment start
- Active brain metastases or carcinomatous meningitis
- HIV infection
- History or current pneumonitis
- Allergic reactions to similar drugs used in this study
- Prior invasive cancers within 3 years except certain skin or localized cancers
- Medical conditions requiring chronic systemic steroids or immunosuppressive drugs
- History of chronic autoimmune diseases with symptoms in past 3 years (except vitiligo)
- QTc interval 480 msec or higher or risk factors for heart rhythm issues
- Unable to tolerate prior immune checkpoint inhibitor therapy
- Uncontrolled illness or psychiatric/social conditions limiting study compliance
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive a combination treatment with CDX-1140, oxaliplatin, capecitabine, and Keytruda for advanced biliary tract carcinoma.
Participants have intravenous infusions of oxaliplatin on Day 1, and CDX-1140 and Keytruda on Day 8 of each 21-day cycle, and take oral capecitabine twice daily for 2 weeks followed by 1 week off per cycle.
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Donna Hrones, C.R.N.P.
T
Tim F Greten, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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