2024-0279 first-line CTX-009 with gemcitabine, cisplatin, and durvalumab
11 evidence topics · 2 sources
Objective
Primary and secondary objectives
Location and study date
Study dates, status, and site: registry record
| Milestone | Registry record |
|---|---|
| Study start (actual) | “2025-01-22” |
| Primary completion (estimated) | “2027-05-01” |
| Enrollment (estimated) | “50” |
| Recruitment status | “Recruiting” |
| Last update posted | “2026-09-09” |
Study design
Sponsor description of the investigator-sponsored trial
Eligibility criteria
Key inclusion criteria: registry record
| Criterion | Quoted registry text |
|---|---|
| Age | “Age ≥ 18 years.” |
| Diagnosis and prior therapy | “Histologically or cytologically confirmed (outside pathology reports will be accepted) unresectable advanced, metastatic, or recurrent BTC at the time of enrollment that has not been previously treated in the metastatic setting.” |
| Performance status | “ECOG performance status ≤2” |
Treatment
Registered interventions
Doses and schedules of each agent
No evidence found.
Study outcomes
Rationale for using incidence of adverse events as the primary endpoint
Registered primary outcome measure
Justification of the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
No evidence found.
Study limitations
Summary
This is an investigator-sponsored phase 1/2 trial at a single institution with an estimated enrollment of 50 participants and no randomization or comparator arm. Its primary outcome measures are the incidence of adverse events and 6-month progression-free survival, so it is designed to establish tolerability and a maximum tolerated dose of CTX-009 added to gemcitabine, cisplatin, and durvalumab rather than to demonstrate efficacy. The population is first-line and previously untreated in the metastatic setting, which is a different population from the second-line population of COMPANION-002. Estimated primary completion is May 1, 2027, and no results had been posted or presented as of the September 9, 2026 registry update. The registry record does not state the doses or schedules of the four agents.