OncoMatch/Clinical Trials/NCT05849480
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Is NCT05849480 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Keytruda and CDX-1140 for biliary cancer.
Treatment: oxaliplatin · capecitabine · Keytruda · CDX-1140 — Background: Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low. Objective: To test a study drug (CDX-1140) combined 3 other drugs (capecitabine, oxaliplatin, Keytruda) in people with BTC. Eligibility: Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant. Design: Participants will be screened. They will have a physical exam. They will have blood tests and tests of their heart function. They will have imaging scans. They may need to have a biopsy: A small sample of tissue will be taken from their tumor using a small needle. Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm (intravenous). The fourth drug is a pill taken by mouth with water. Participants will be treated in 21-day cycles. They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles. After that, they will receive intravenous treatments only on day 1 of each cycle. Participants will take the pill twice a day only for the first 2 weeks of each cycle. They will stop taking this drug after 6 cycles. Imaging scans will be repeated every 9 weeks. Participants may continue receiving the study treatment for up to 2 years. Follow-up visits, including imaging scans, will continue for 3 more years. These images may be taken at other locations and sent to the researchers.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic treatment — first line
Participants should have progressed on standard of care first line systemic treatment or refused standard treatment
Cannot have received: anti-CD40
Prior therapy with anti-CD40
Cannot have received: standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigation agents) or large field radiotherapy
Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigation agents) or large field radiotherapy within 4 weeks prior to treatment initiation
Lab requirements
Blood counts
ANC >= 1,000/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <1.5x institution upper limit of normal OR >= 45 mL/min/1.73 m2 for participant with creatinine levels >= 1.5 X institutional ULN
Liver function
Total bilirubin <= 2.5 x ULN; ALT and AST <= 5 x ULN
Cardiac function
Fridericia's corrected QT interval (QTcF) < 480 msec
Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) >= 1,000/mcL Platelets >= 100,000/mcL Total bilirubin <= 2.5 x ULN ALT and AST <= 5 x ULN. Creatinine <1.5x institution upper limit of normal OR >= 45 mL/min/1.73 m2 for participant with creatinine levels >= 1.5 X institutional ULN Fridericia's corrected QT interval (QTcF) >= 480 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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