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Brief Title: A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Official Title: 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
Study ID: NCT05506943
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
University of Chicago, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States
Rutgers Cancer Institute, New Brunswick, New Jersey, United States
The University of New Mexico, Albuquerque, New Mexico, United States
Memorial Medical Center, Las Cruces, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park, Buffalo, New York, United States
Columbia University, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Texas Oncology - Austin, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Dension, Denison, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology - San Antonio, San Antonio, Texas, United States
Texas Oncology - Northeast Texas, Tyler, Texas, United States
Virginia Mason Franciscan Health, Seattle, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Name: Minori Rosales, MD, PHD
Affiliation: Compass Therapeutics
Role: STUDY_DIRECTOR