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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: Recruiting Phase 1 study of Bile Duct Cancer and Biliary Cancer, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Estimation of safe dose will be determined based on number of dose limiting toxicities (DLTs) experienced.
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 |
What NCT05849480 shows while recruiting
NCT05849480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 260-participant average among 10 other Bile Duct Cancer trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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
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Where NCT05849480's enrollment target sits among peer trials
60 7th of 10 higher than 4 of 10 other Bile Duct Cancer trials
participants (enrollment target), bucketed by value
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