A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)

Recruiting now · Phase 1/Phase 2

Conditions studied: Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct

In brief

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.

Key facts

Study ID

NCT05849480

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2024-05-08

Expected to finish

2042-06-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• Prior therapy with anti- CD40.
• Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist(R)) are live attenuated vaccines and are not allowed.
• Major surgery within 4 weeks prior to treatment initiation.
• Active central nervous system metastases and/or carcinomatous meningitis.
• HIV-infected participants.
• History of (non-infectious) pneumonitis or current pneumonitis.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or other agents used in study, such as nivolumab, dacetuzumab, APX005M, ADC-1013.
• Prior invasive malignancies within the past 3 years prior to treatment initiation (with the exception of non-melanoma skin cancers, non-invasive bladder cancer, or localized prostate cancer for whom systemic therapy is not required).
• Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).
• History of chronic autoimmune disease (e.g., Addison's disease, multiple sclerosis, Graves' disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, systemic lupus erythematosus, Wegener's granulomatosis, sarcoidosis syndrome, etc.) or other connective tissue diseases with the symptomatic disease within the 3 years of initiation of study treatment. Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion.
• 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.
• Participants who were not able to tolerate prior immune checkpoint inhibitor therapy.
• Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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