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 – COMPANION-002

• Beyond First Line Therapy
• Chemotherapy
• Immunotherapy

Arizona Locations
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Contact: Clinical Trials Referral Office, 855-776-0015
Principal Investigator: Mitesh Borad, MD

University of Arizona
Tucson, Arizona, United States, 85054
Contact: Brianna Loughran, bloughran@arizona.edu
Contact: Prisca Zimmerman, priscaz@arizona.edu
Principal Investigator: Rachna T Shroff, MD

California Locations
University of California – San Francisco
San Francisco, California, United States, 94143-1770
Contact: Quincy Harris, Quincy.Harris@ucsf.edu
Contact: Maxine Hamilton, Maxine.Hamilton2@ucsf.edu
Principal Investigator: Katie Kelley, MD

University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Contact: Angelina Lee, Angelina.Lee@med.usc.edu
Principal Investigator: Anthony El-Khoueiry, MD

Stanford Medicine Cancer Center
Palo Alto, California, United States, 94305
Contact: Yasmeen Ahmed, yahmed@stanford.edu
Principal Investigator: Gregory Heestand, MD

Colorado Locations
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
Contact: Jennifer Hege, jennifer.hege@usoncology.com
Principal Investigator: Sujatha Nallapareddy, MD

Florida Locations
University of Florida
Gainesville, Florida, United States, 32611
Contact: Allison Springer, Med, sheehanallison@ufl.edu
Principal Investigator: Ilyas Sahin, MD

Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Referral Office, 855-776-0015
Principal Investigator: Umair Majeed, MD

AdventHealth Orlando
Orlando, Florida, United States, 32804
Contact: Anh Le, 407-303-8274, anh.le@adventhealth.com
Principal Investigator: Mohamedtaki Tejani, MD

Illinois Locations
Northwestern University
Chicago, Illinois, United States, 60611
Contact: Mohammed Abdulrahman Mohammed, mohammedabdulrahman.mohamm@northwestern.edu
Contact: Anastasia Papaioannou, 630-938-2085, anastasia.papaioannou@nm.org
Principal Investigator: Aparna Kalyan, MD

University of Chicago
Chicago, Illinois, United States, 60637
Contact: Hang Chang, 773-702-3482, hchang@bsd.uchicago.edu
Contact: cancerclinicaltrials@bsd.uchicago.edu
Principal Investigator: Chih-Yi (Andy) Liao, MD

Louisiana Locations
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Contact: Elise Curry, CRC, 504-842-8084, elisemarie.curry@ochsner.org
Contact: Nancy Perez, CRC, 504-842-0179, nancy.perez@ochsner.org
Principal Investigator: Lingling Du, MD

Maryland Locations
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Contact: Nilofer Azad, MD, 202-365-0105 Nazad2@jhmi.edu
Contact: Christy Liu, Lead Nurse, xliu208@jhmi.edu
Principal Investigator: Nilofer Azad, MD

Massachusetts Locations
Massachusetts General Hospital
Boston, Massachusetts, United States, 02141
Contact: Joanna Caufield, RN jlcaufield@mgb.org
Contact: Ashley O’Meara, ALOMEARA@mgh.harvard.edu
Principal Investigator: Priyadarshini Pathak, MD

Minnesota Locations
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office, 855-776-0015
Principal Investigator: Nguyen Tran, MD

Missouri Locations
Washington University School of Medicine, Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Contact: David Timm, 314-215-7337 Ti,mmd@wustl.edu
Principal Investigator: Olivia Aranha, MD

New Jersey Locations
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08854
Contact: Lead Clinical Research Coordinator, perez11@cinj.rutgers.edu
Contact: Back-Up Clinical Research Coordinator, uq5@cinj.rutgers.edu
Principal Investigator: Howard Hochster, MD

New Mexico Locations
The University of New Mexico
Albuquerque, New Mexico, United States, 87131
Contact: glritcher@salud.unm.edu
Contact: lmancha@salud.unm.edu
Principal Investigator: Ursa Brown-Glaberman, MD

Memorial Medical Center
Las Cruces, New Mexico, United States, 88011
Contact: glritcher@salud.unm.edu
Contact: lmancha@salud.unm.edu
Principal Investigator: Ursa Brown-Glaberman, MD

New York Locations
Columbia University
New York, New York, United States, 10032
Contact: Kriti Bagri Manjrekar, kb3315@cumc.columbia.edu
Principal Investigator: Ruth White, MD

Montefiore Medical Center
Bronx, New York, United States, 10461
Contact: Chika Ekweghariri, cekweghari@montefiore.org
Principal Investigator: Fernand Bteich, MD

Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Contact: Mary Lynne Tarquini, marylynne.tarquini@roswellpark.org
Contact: Sarah Chatley, sarah.chatley@roswellpark.org
Principal Investigator: Renuka Iyer, MD

Ohio Locations
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Cancer Center Hotline 866-223-8100      
Principal Investigator: Suneel Kamath, MD  

Gabrail Cancer Center
Canton, Ohio, United States, 44718
Contact: Nashat Gabrail, research@gabrailcancercenter.com
Principal Investigator: Nashat Y Gabrail, MD

Tennessee Locations
Tennessee Oncology Nashville (SCRI Oncology Partners) 
Nashville, Tennessee, United States, 37203
Contact: AskSARAH, 844-482-4812
Principal Investigator: Meredith Pelster, MD

University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Contact: Dani Joyner, BSN, RN, OCN, 865-305-3565, jdjoyner@utmck.edu
Principal Investigator: Saikrishna Gadde, MD

Texas Locations
Texas Oncology – Austin
Austin, Texas, United States, 78705
Contact: Jennifer Rowan, jennifer.rowan@usoncology.com
Principal Investigator: Vivian Cline, MD

Texas Oncology – Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Contact: Christine Terraciano, Christine.terraciano@usoncology.com
Principal Investigator: Andrew Scott Paulson, MD

Texas Oncology – Dension
Denison, Texas, United States, 75020
Contact: Jayne Mettetal, jayne.mettetal@usoncology.com
Principal Investigator: Amir Faridi, MD

The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: GIClinicalTrials@mdanderson.org
Principal Investigator: Zishuo Ian Hu, MD

Texas Oncology – San Antonio
San Antonio, Texas, United States, 78217
Contact: Shannon Syring, shannon.syring@usoncology.com
Principal Investigator: Nathan Shumway, DO

Texas Oncology – Northeast Texas
Tyler, Texas, United States, 75702
Contact: Shelly K Maxfield, shelly.maxfield@usoncology.com
Principal Investigator: Donald A Richards, MD, PhD

Washington Locations
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Contact: Jennifer Thompson, jennifer.thompson@usoncology.com
Principal Investigator: David P Cosgrove, MD

• Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.

• 18 years of age and older
• Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
• Patients must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as initial therapy for locally advanced or metastatic disease. Patients who relapse within 6 months of receiving gemcitabine and platinum containing chemotherapy regimen in the adjuvant setting are also eligible.
• At least one lesion measurable as defined by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Predicted life expectancy of at least 12 weeks
• No evidence of ongoing infection and adequate biliary excretion or patients whose adequate biliary excretion can be confirmed with the following procedures: Patients who underwent endoscopic retrograde biliary drainage (ERBD) at least 1 week before the investigational drug treatment; Patients who underwent percutaneous transhepatic biliary drainage (PTBD) at least 4 weeks before the investigational drug treatment; Patients free of any signs of active or suspected uncontrolled infection after a drainage procedure; Patients free of any risk of hemorrhage and with incision completely healed
• Adequate bone marrow, hepatic, and renal function within 14 days of randomization as described in the study protocol (Patient must be free of granulocyte colony-stimulating factor (G-CSF) treatment and blood transfusion within 14 days prior to the lab test)
• Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-human chorionic gonadotropin (hCG) or urine-hCG performed at the Investigator’s discretion) within 14 days of randomization
• Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment.
• Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

• Patients who are eligible to be treated with a molecularly targeted therapy on a labelled regimen after receiving first-line chemotherapy
• From the time point of screening, Less than 4 weeks have elapsed since patients had a surgery or major procedure and Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
• Prior to the initial treatment of study drug, Less than 2 weeks have elapsed since patients had chemotherapy or hormone therapy (However, patients cannot participate when nitrosoureas or mitomycin was administered within 6 weeks) and/or Less than 2 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment and/or Less than 6 weeks since cryotherapy, radiofrequency ablation, anhydrous alcohol therapy, or photodynamic therapy
• A history of cardiovascular disease in the past 5 years as defined in the study protocol
• History of hypersensitivity reactions to any components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody drugs) or paclitaxel
• Patients with contraindications to paclitaxel therapy
• Patients with persistent, clinically significant toxicities (excluding hair loss) from previous anticancer treatment that corresponds to Grade 2 or a higher grade under NCI-CTCAE v5.
• Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving)
• A history of the following hemorrhage-related or gastroenterological disease: Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor in great arteries and/or History of clinically significant gastroenterological disease, such as peptic ulcer, GI bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms, and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease (IBD)
• Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) within 2 weeks prior to screening, or is expected to need those drugs during the clinical study
• Patients requiring continuous treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids (the following cases are permitted): NSAIDs: Up to 3 consecutive days’ use is permitted; Corticosteroids: Topical use of corticosteroids, such as topical intra-articular injection, intranasal administration, eye drops, inhaler, etc., or temporary systemic corticosteroid use for treatment and prevention of patient’s contrast media allergy, paclitaxel pre-treatment, or adverse event, is permitted
• Severe infection requiring systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases
• Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.
• Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study (permitted only if medically controlled) including but not limited to as described in the study protocol
• Patients expected to require anticancer treatment other than the investigational product during the clinical study
• Pregnant or lactating patients, or patients planning to become pregnant during the clinical study
• A history of primary malignant tumor other than biliary tract cancer with the following exceptions: At least 3 years have passed since complete remission of primary malignant tumor (Patients who had papillary thyroid carcinoma and underwent a radical resection may participate in the clinical study even if less than 3 years have elapsed); At least 1 year has passed since complete resection of dermal basal cell carcinoma or successful treatment of cervical intraepithelial neoplasia
• Clinically significant abnormal ECG findings or history determined as clinically significant by the Investigator
• QT interval (Fridericia’s formula) (QTcF) interval > 450msec at the time of screening

• Medical History
• Vital Signs
• ECG (Heart Tracting)
• Echocardiogram
• Physical Exam
• CT or MRI
• Blood and urine samples
• Pregnancy test (if applicable)

• CTX-009 is still being tested in people and the complete side effects may still be unknown. The below is a list of study treatment emergent adverse events observed in ≥ 10% (more than 3 of 24) study participants with biliary tract cancer who received CTX-009 in combination with Paclitaxel:
• Anemia (low red blood count); Neutropenia (low white blood cell count)
• Abdominal pain; Ascites (swelling); Constipation; Diarrhea; Indigestion; Nausea
• Fatigue (tiredness); Fever; Mucosal (the lining of your stomach and intestines); Inflammation; Edema (swelling); Weakness
• Liver abscess (pocket of pus); Liver infection
• Aspartate aminotransferase increased; Blood bilirubin increased; Neutrophil (white blood cells) count decreased; Platelet count decreased
• Decreased appetite
• Muscle pain
• Headache; Neuropathy peripheral (damage to nerves in your body)
• Protein in urine
• Cough; Difficulty speaking; Difficulty breathing; Nosebleed; Pulmonary hypertension (high blood pressure in the lungs)
• Itchy skin
• Hypertension (high blood pressure)