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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)

A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen

NCT05506943•Compass Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or older
•2. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
•3. Patients must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as first line therapy for locally advanced unresectable or metastatic disease.
•1. Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor.
•2. Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor.
•4. At least one lesion measurable as defined by RECIST v1.1
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•6. Predicted life expectancy of at least 12 weeks
•7. No evidence of ongoing infection and adequate biliary excretion or patients whose adequate biliary excretion can be confirmed with the following procedures:
•1. Patients who underwent endoscopic retrograde biliary drainage (ERBD) at least 1 week before the investigational drug treatment
+16 more criteria

Exclusion Criteria

•1. Patients who are eligible to be treated with a molecularly targeted therapy on a labelled regimen after receiving first-line chemotherapy. Patients who received a molecularly targeted therapy as part of their first line treatment may be eligible, as determined by the Sponsor Medical Monitor.
•2. From the time point of screening,
•1. Less than 4 weeks have elapsed since patients had a surgery or major procedure
•2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
•3. Patients with percutaneous transhepatic biliary drains (PTBD)
•4. Prior to the initial treatment of study drug,
•1. Less than 2 weeks have elapsed since patients had chemotherapy or hormone therapy
•2. Less than 2 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
•3. Less than 4 weeks since cryotherapy, radiofrequency ablation, anhydrous alcohol therapy, or photodynamic therapy, including TACE and TARE
•5. A history of the following cardiovascular diseases (please, consult the Sponsor Medical Monitor for a case by case evaluation):
+31 more criteria

Locations (34)

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Medicine Cancer Center

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

January 9, 2023

Primary Completion Date

July 1, 2025

Completion Date

December 1, 2025

Last Updated

April 20, 2025

Enrollment

150

ESTIMATED participants

Conditions

Biliary Tract CancerCholangiocarcinomaGall Bladder CancerAmpullary Cancer

Interventions

CTX-009

DRUG

Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

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Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients