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A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
NCT05506943 · View on ClinicalTrials.gov ↗
Study Summary
This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG CTX-009
Study Locations (20)
California
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles
- Stanford Medicine Cancer Center — Palo Alto
- University of California San Francisco — San Francisco
Florida
- University of Florida — Gainesville
- Mayo Clinic Jacksonville — Jacksonville
- AdventHealth Orlando — Orlando
Arizona
- Mayo Clinic Arizona — Phoenix
- University of Arizona — Tucson
Illinois
- Northwestern University — Chicago
- University of Chicago — Chicago
New Mexico
- The University of New Mexico — Albuquerque
- Memorial Medical Center — Las Cruces
Colorado
- Rocky Mountain Cancer Centers, LLP — Aurora
Louisiana
- Ochsner Clinic Foundation — New Orleans
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05506943
The ClinicalTrials.gov registry entry for NCT05506943 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Compass Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions — of which Paclitaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05506943 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05506943 about?
NCT05506943 is a clinical study titled "A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)". This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
What is the current status of trial NCT05506943?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-01-09. Estimated completion is 2025-12.
What conditions does trial NCT05506943 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Biliary Tract Cancer, Gall Bladder Cancer, Ampullary Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05506943?
The interventions under investigation include: Paclitaxel (DRUG), CTX-009 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05506943?
This trial is sponsored by Compass Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05506943 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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