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Monoclonal Antibodies

CTX-009 + Paclitaxel for Biliary Tract Cancer

Phase 2 & 3
Recruiting
Research Sponsored by Compass Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial compares a new drug plus paclitaxel versus just paclitaxel for advanced biliary tract cancer.

Who is the study for?
Adults over 18 with advanced, metastatic or recurrent biliary tract cancers including gallbladder and ampullary cancer. They must have had previous chemotherapy, be in good physical condition (ECOG 0-1), and not be at risk of bleeding. Women must use birth control and men should too if they're not sterile.Check my eligibility
What is being tested?
The trial is testing CTX-009 combined with Paclitaxel against Paclitaxel alone in patients who've already been treated for their cancer. It's an open-label study where everyone knows what treatment they're getting, and it's randomized to compare the results fairly.See study design
What are the potential side effects?
Possible side effects include those common to antibody treatments like allergic reactions, as well as those associated with chemotherapy such as nausea, hair loss, nerve damage, muscle aches, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is in the bile ducts and cannot be removed by surgery.
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My cancer progressed after initial treatment with gemcitabine and platinum.
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I am fully active or can carry out light work.
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Your doctor believes you are likely to live for at least 12 more weeks.
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I had a procedure to drain my bile duct at least 1 week ago.

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response
Secondary outcome measures
Disease Control Rate
Duration of Response
Exposure Response by Pharmacokinetic (PK) Sampling
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CTX-009 plus PaclitaxelExperimental Treatment2 Interventions
Group II: PaclitaxelActive Control1 Intervention
Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Compass TherapeuticsLead Sponsor
4 Previous Clinical Trials
388 Total Patients Enrolled
Minori Rosales, MD, PHDStudy DirectorCompass Therapeutics
Thomas J Schuetz, MD, PHDStudy DirectorCompass Therapeutics

Media Library

Biliary Tract Cancer Clinical Trial 2023: CTX-009 Highlights & Side Effects. Trial Name: NCT05506943 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this research study?

"Indeed, the data on clinicaltrials.gov confirms that this research trial is currently enrolling participants. It was first posted on September 1st 2023 and has been updated most recently in the same month; 150 patients are required between 2 separate sites."

Answered by AI

Are there any current openings for participants in this trial?

"Affirmative. According to information on clinicaltrials.gov, this experiment is currently looking for 150 volunteers across 2 sites. This trial was first published on the 9th of January 2023 and has been recently updated as well."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Washington University School of Medicine, Siteman Cancer Center
University of Tennessee Medical Center
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
2023. "A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05506943.
All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer
~67 spots leftby Apr 2025
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