A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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
1 other identifier
interventional
168
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2023
Typical duration for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 18, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2026
CompletedApril 30, 2026
April 1, 2026
3 years
August 15, 2022
April 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Best Overall Response
Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1
From randomization to treatment discontinuation for any reason, average 6 months
Secondary Outcomes (5)
Progression Free Survival
From randomization to first documented objective PD or death if PD does not occur, average 6 months
Duration of Response
From first confirmed CR or PR to confirmed PD, average 6 months
Overall Survival
From randomization to death from any cause, average 12 months
Disease Control Rate
From randomization to treatment discontinuation for any reason, average 6 months
Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities
From randomization to 60 days after the last dose of study treatment, average 7 months
Study Arms (2)
CTX-009 plus Paclitaxel
EXPERIMENTALPaclitaxel
ACTIVE COMPARATORPatients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.
Interventions
IV infusion on day 1, 8, and 15 of every 28 day cycle
Eligibility Criteria
You may qualify if:
- 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
- +11 more criteria
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
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
University of Arizona
Tucson, Arizona, 85724-5024, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford Medicine Cancer Center
Palo Alto, California, 94305, United States
University of California San Francisco
San Francisco, California, 94143-1770, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
University of Florida
Gainesville, Florida, 32611, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02141, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08854, United States
The University of New Mexico
Albuquerque, New Mexico, 87131, United States
Memorial Medical Center
Las Cruces, New Mexico, 88011, United States
Roswell Park
Buffalo, New York, 14263, United States
Columbia University
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - Austin
Austin, Texas, 78705, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Dension
Denison, Texas, 75020, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78217, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Virginia Mason Franciscan Health
Seattle, Washington, 98101, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Related Publications (1)
Azad N, Hu Z, Sahin I, Iyer R, Aranha O, Hochster H, Pathak P, Paulson AS, Kalyan A, Liao CY, Tran N, Kelley RK, Heestand G, Cosgrove D, El-Khoueiry A, Borad M, Gabrail NY, Majeed U, Du L, Kamath S, Shumway N, Shroff R, Goyal L, Rosales M, Javle M. COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC. Future Oncol. 2024;20(30):2241-2248. doi: 10.1080/14796694.2024.2351351. Epub 2024 Jun 4.
PMID: 38861293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cynthia Sirard, MD
Compass Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A blinded independent review committee will be used to assess the primary study endpoint.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2022
First Posted
August 18, 2022
Study Start
January 9, 2023
Primary Completion
January 21, 2026
Study Completion
January 21, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04