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NCT06548412 · ClinicalTrials.gov registry record · Phase 1
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
A Phase 1 study of Metastatic Biliary Tract Cancer, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06548412: Recruiting Phase 1 study of Metastatic Biliary Tract Cancer, sponsored by M.D. Anderson Cancer Center.
NCT06548412 is a Phase 1 study of Metastatic Biliary Tract Cancer that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548412, a Phase 1 study of Metastatic Biliary Tract Cancer, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Durvalumab
- DRUG CTX-009
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2029-05-01 |
| Phase | Phase 1 |
What NCT06548412 shows while recruiting
NCT06548412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Metastatic Biliary Tract Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.
NCT06548412 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06548412 about?
NCT06548412 is a clinical study titled "CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers". To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
What is the current status of trial NCT06548412?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-01-22. Estimated completion is 2029-05-01.
What conditions does trial NCT06548412 study?
This clinical trial studies the following conditions: Metastatic Biliary Tract Cancer.
What interventions are being tested in trial NCT06548412?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Durvalumab (DRUG), CTX-009 (DRUG).
Who is sponsoring clinical trial NCT06548412?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06548412 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06548412's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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