NCT05849480RecruitingPhase 1/2

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

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)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 8 May 2023
Start date: 8 May 2024
Primary completion date: 1 Jun 2040
Lead sponsor: National Cancer Institute (NCI)
Diseases: Liver and biliary tract cancer
NCT number: NCT05849480

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 60
From 8 May 2024 to the primary completion date, 1 Jun 2040
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
Participants who were not able to tolerate prior immune checkpoint inhibitor therapy.

Other illness

History of a homozygous or compound heterozygous variants in the DPYD gene associated with complete or near complete absence in dihydropyridimidine dehydrogenase (DPD) activity.
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.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.

Lab values

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.

Other

Active central nervous system metastases and/or carcinomatous meningitis.
Pregnancy.

Criteria the registry did not label

INCLUSION CRITERIA:
Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC.
The maximum tumor size of any individual tumor or metastasis must be \<= 8 cm.
Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.
Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.
Participants must have evaluable or measurable disease per RECIST 1.1
ECOG performance status of 0 to 1
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 OR Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl)
- \<1.5x institution upper limit of normal OR
- \>= 45 mL/min/1.73 m2 for participant with creatinine levels
- \>= 1.5 X institutional ULN
Age \>=18 years.
Participants must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be \<= grade 1. Note: participants with thyroid dysfunction caused by prior therapy including the need for chronic therapy are eligible.
Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the study entry, for the duration of study treatment and up to 4 months after the last dose of the CDX-1140 or Keytruda(R) (all individuals), 9 months (IOCBP), 6 months (individuals able to father a child) after completion of CAPOX therapy whatever comes later
Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after study treatment discontinuation.
HBV-infected participants must be on antivirals and have HBV DNA \<100 IU/mL. HCV-infected participants can be enrolled if HCV RNA level is undetectable.
Participants must be able to understand and willing to sign a written informed consent document.

Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.