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

ACTIVE, NOT RECRUITING

Study Name
	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
ClinicalTrials.gov Identifier (if applicable)
	NCT05506943
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Chemotherapy Immunotherapy
Study Center
Institution Name
	The University of New Mexico
City
	Albuquerque
State
	New Mexico
Zip Code
	87131
Country
	United States
List additional Institutions (include address, phone number, and website)
	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 Virginia Mason Franciscan Health Seattle, Washington, United States, 98101 Contact: Cancer Clinical Research Unit Research Hotline 206-287-6270 Contact: Bruce Lin, 206-223-6193, bruce.lin@virginiamason.org Principal Investigator: Bruce Lin, MD
Study Contacts
Principal Investigator
	Ursa Brown-Glaberman
P.I. Phone
	(505) 272-4946
P.I. Email
	ubglaberman@salud.unm.edu
Study Coordinator
	Compass Therapeutics
Study Coordinator Phone
	(617) 500-8099
Study Coordinator Email
	CTX-009-002@compasstherapeutics.com
OVERVIEW – in layman’s terms (150 words max)
	Compass Therapeutics is studying an experimental drug called CTX-009 in patients with previously treated, unresectable advanced or metastatic biliary tract cancers. This is an experimental drug being developed to potentially stimulate the immune system to fight against cancer.
Enrollment
	150
Study Start Date
	01/09/2023
Estimated Completion Date
	12/31/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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.
Inclusion Criteria – Patients Must:
	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
Exclusion Criteria – Patients Must NOT:
	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
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Medical History Vital Signs ECG (Heart Tracting) Echocardiogram Physical Exam CT or MRI Blood and urine samples Pregnancy test (if applicable)
POTENTIAL SIDE-EFFECTS – in layman’s terms
	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)