Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05849480 · ClinicalTrials.gov registry record · Phase 1
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 1 study of Bile Duct Cancer and Biliary Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05849480 is a Phase 1 study of Bile Duct Cancer and Biliary Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 260-participant average among 10 other Bile Duct Cancer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05849480, a Phase 1 study of Bile Duct Cancer and Biliary Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG oxaliplatin
- DRUG capecitabine
- BIOLOGICAL Keytruda
- BIOLOGICAL CDX-1140
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-08 |
| Est. Completion | 2042-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05849480
The ClinicalTrials.gov registry entry for NCT05849480 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 10 other Bile Duct Cancer trials with a reported enrollment target (77% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bile Duct Cancer appearing as the primary indexed condition, and to 4 interventions - of which oxaliplatin is the first listed.
NCT05849480 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05849480 about?
NCT05849480 is a clinical study titled "A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)". 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, Keytru...
What is the current status of trial NCT05849480?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-05-08. Estimated completion is 2042-06-01.
What conditions does trial NCT05849480 study?
This clinical trial studies the following conditions: Bile Duct Cancer, Biliary Cancer, Cancer of the Bile Duct.
What interventions are being tested in trial NCT05849480?
The interventions under investigation include: oxaliplatin (DRUG), capecitabine (DRUG), Keytruda (BIOLOGICAL), CDX-1140 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05849480?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849480 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bile Duct Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
-
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
COMPLETED · Phase 1
-
Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)
RECRUITING · Phase 2
-
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
RECRUITING
-
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
RECRUITING · NA
-
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.