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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Biliary Tract Cancer, Cholangiocarcinoma, Gall Bladder Cancer, Ampullary Cancer

In brief

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.

Key facts

Study ID

NCT05506943

Run by

Compass Therapeutics

People needed

168

Starts

2023-01-09

Expected to finish

2026-12-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or 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 first line therapy for locally advanced unresectable or metastatic disease.
• Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor.
• Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor.
• 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 with endobiliary stents are eligible, provided there is no evidence of obstruction
• 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 below. (Patient must be free of G-CSF treatment and blood transfusion within 14 days prior to the lab test):
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 X ULN
• AST/ALT ≤ 3.0 X ULN (≤5 X ULN in case of hepatic metastasis)
• Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault
• Urine protein ≤ 1+ by Dipstick (Only when urinalysis shows a protein dipstick result of > 1 positive (+), the total protein volume (<1.0 g/24hr) can be confirmed with a 24-hour urine test.)
• Serum amylase and lipase level ≤ 3X ULN
• Serum Albumin ≥ 3.0 g/dL
• Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-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, or any form of hormonal contraceptives) or abstinence for the duration of the study and for 6 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 6 months following the last dose of study treatment.

You may not qualify if…

• 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.
• From the time point of screening,
• Less than 4 weeks have elapsed since patients had a surgery or major procedure
• Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
• Patients with percutaneous transhepatic biliary drains (PTBD)
• Prior to the initial treatment of study drug,
• Less than 2 weeks have elapsed since patients had chemotherapy or hormone therapy
• Less than 2 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
• Less than 4 weeks since cryotherapy, radiofrequency ablation, anhydrous alcohol therapy, or photodynamic therapy, including TACE and TARE
• A history of the following cardiovascular diseases (please, consult the Sponsor Medical Monitor for a case by case evaluation):
• Congestive heart failure (CHF) that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification, or less than 50% of left ventricular ejection fraction (LVEF)
• Uncontrolled hypertension (SBP/DBP >140/90 mmHg) (e.g., patient with SBP/DBP >140/90 mmHg despite the best care including optimizing the anti-hypertensive medication regimen)
• Patients with any history of hypertensive crisis or pre-existing hypertensive encephalopathy
• Pulmonary hypertension
• Myocardial infarction
• Uncontrolled arrhythmia
• Unstable angina
• Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product
• 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 v5.0
• Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis that have been treated with either surgery or radiation 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
• 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)

Where it is running

• 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 — St 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
• Roswell Park — Buffalo, New York, United States
• Columbia University — New York, New York, United States
• Montefiore Medical Center — The Bronx, 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

Full record on ClinicalTrials.gov

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