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

ClinicalTrials.gov Identifier

NCT05506943

Institution Name

The University of New Mexico

Full Institution Address

Albuquerque New Mexico 87131 United States

Additional Institutions

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, [email protected] Contact: Prisca Zimmerman, [email protected] Principal Investigator: Rachna T Shroff, MD California Locations University of California – San Francisco San Francisco, California, United States, 94143-1770 Contact: Quincy Harris, [email protected] Contact: Maxine Hamilton, [email protected] Principal Investigator: Katie Kelley, MD University of Southern California Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033 Contact: Angelina Lee, [email protected] Principal Investigator: Anthony El-Khoueiry, MD Stanford Medicine Cancer Center Palo Alto, California, United States, 94305 Contact: Yasmeen Ahmed, [email protected] Principal Investigator: Gregory Heestand, MD Colorado Locations Rocky Mountain Cancer Centers, LLP Aurora, Colorado, United States, 80012 Contact: Jennifer Hege, [email protected] Principal Investigator: Sujatha Nallapareddy, MD Florida Locations University of Florida Gainesville, Florida, United States, 32611 Contact: Allison Springer, Med, [email protected] 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, [email protected] Principal Investigator: Mohamedtaki Tejani, MD Illinois Locations Northwestern University Chicago, Illinois, United States, 60611 Contact: Mohammed Abdulrahman Mohammed, [email protected] Contact: Anastasia Papaioannou, 630-938-2085, [email protected] Principal Investigator: Aparna Kalyan, MD University of Chicago Chicago, Illinois, United States, 60637 Contact: Hang Chang, 773-702-3482, [email protected] Contact: [email protected] 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, [email protected] Contact: Nancy Perez, CRC, 504-842-0179, [email protected] Principal Investigator: Lingling Du, MD Maryland Locations Johns Hopkins University Baltimore, Maryland, United States, 21287 Contact: Nilofer Azad, MD, 202-365-0105 [email protected] Contact: Christy Liu, Lead Nurse, [email protected] Principal Investigator: Nilofer Azad, MD Massachusetts Locations Massachusetts General Hospital Boston, Massachusetts, United States, 02141 Contact: Joanna Caufield, RN [email protected] Contact: Ashley O'Meara, [email protected] 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,[email protected] Principal Investigator: Olivia Aranha, MD New Jersey Locations Rutgers Cancer Institute New Brunswick, New Jersey, United States, 08854 Contact: Lead Clinical Research Coordinator, [email protected] Contact: Back-Up Clinical Research Coordinator, [email protected] Principal Investigator: Howard Hochster, MD New Mexico Locations The University of New Mexico Albuquerque, New Mexico, United States, 87131 Contact: [email protected] Contact: [email protected] Principal Investigator: Ursa Brown-Glaberman, MD Memorial Medical Center Las Cruces, New Mexico, United States, 88011 Contact: [email protected] Contact: [email protected] Principal Investigator: Ursa Brown-Glaberman, MD New York Locations Columbia University New York, New York, United States, 10032 Contact: Kriti Bagri Manjrekar, [email protected] Principal Investigator: Ruth White, MD Montefiore Medical Center Bronx, New York, United States, 10461 Contact: Chika Ekweghariri, [email protected] Principal Investigator: Fernand Bteich, MD Roswell Park Comprehensive Cancer Center Buffalo, New York, United States, 14263 Contact: Mary Lynne Tarquini, [email protected] Contact: Sarah Chatley, [email protected] 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, [email protected] 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, [email protected] Principal Investigator: Saikrishna Gadde, MD Texas Locations Texas Oncology - Austin Austin, Texas, United States, 78705 Contact: Jennifer Rowan, [email protected] Principal Investigator: Vivian Cline, MD Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas, United States, 75246 Contact: Christine Terraciano, [email protected] Principal Investigator: Andrew Scott Paulson, MD Texas Oncology - Dension Denison, Texas, United States, 75020 Contact: Jayne Mettetal, [email protected] Principal Investigator: Amir Faridi, MD The University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030 Contact: [email protected] Principal Investigator: Zishuo Ian Hu, MD Texas Oncology - San Antonio San Antonio, Texas, United States, 78217 Contact: Shannon Syring, [email protected] Principal Investigator: Nathan Shumway, DO Texas Oncology - Northeast Texas Tyler, Texas, United States, 75702 Contact: Shelly K Maxfield, [email protected] Principal Investigator: Donald A Richards, MD, PhD Washington Locations Northwest Cancer Specialists, P.C. Vancouver, Washington, United States, 98684 Contact: Jennifer Thompson, [email protected] 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, [email protected] Principal Investigator: Bruce Lin, MD

Principal Investigator

Ursa Brown-Glaberman

Principal Investigator Phone

(505) 272-4946

Principal Investigator Email

[email protected]

Study Coordinator

Compass Therapeutics

Study Coordinator Phone

(617) 500-8099

Study Coordinator Email

[email protected]

Study Overview

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 Information

150

Study Start Date

20230109

Study End Date

20241231

Study Purpose

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

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

atients 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 Study

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

Potential Side Effects

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)

Financial Assistance Available

Yes

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