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Biliary Tract CancerPhase 2/3NCT05506943

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 study testing CTX-009 and Paclitaxel in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Compass Therapeutics at 34 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CTX-009 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
34 sitesUnited States
Study dates
9 Jan 2023to 31 Aug 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

Who cannot join

  • 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,
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  • 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)
  • Current or recent (within 10 days prior to study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose will be excluded.
  • Prophylactic (i.e., for the patency of venous access devices) use of low molecular weight heparin (i.e., enoxaparin 40 mg/day) is allowed if patient has INR < 2 or aPTT </=2x ULN within 14 days of study treatment
  • Patients with current or recent (within 10 days of study treatment) use of aspirin (>81 mg/day), or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other antiplatelets (i.e., dipyramidole, ticlopidine, clopidogrel, and cilostazol) will be excluded.
  • Severe infection requiring ongoing 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:
  • Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening
  • Major, unhealed injury, active ulcer, or untreated fracture
  • Pre-existing conditions of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening.
  • Moderate to severe ascites and/or pleural effusion. However, enrollment is permitted for patients with ascitic fluid as long as paracentesis is not required to improve the condition.
  • Interstitial lung disease or pulmonary fibrosis
  • 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 malignancy other than BTC will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.
  • 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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • The University of New Mexico

    Albuquerque, New Mexico, 87131

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Texas Oncology - Austin

    Austin, Texas, 78705

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02141

  • Roswell Park

    Buffalo, New York, 14263

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology - Dension

    Denison, Texas, 75020

  • University of Florida

    Gainesville, Florida, 32611

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Memorial Medical Center

    Las Cruces, New Mexico, 88011

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08854

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University

    New York, New York, 10032

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Stanford Medicine Cancer Center

    Palo Alto, California, 94305

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78217

  • University of California San Francisco

    San Francisco, California, 94143-1770

  • Virginia Mason Franciscan Health

    Seattle, Washington, 98101

  • Washington University School of Medicine, Siteman Cancer Center

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • University of Arizona

    Tucson, Arizona, 85724-5024

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

Other trials in United States

About this study

Official title: 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

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.

Being tested
CTX-009, Paclitaxel
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTX-009Drug

    IV infusion on day 1 and 14 of every 28 day cycle

  • PaclitaxelDrug

    IV infusion on day 1, 8, and 15 of every 28 day cycle

Study groups in NCT05506943
Study groupRoleWhat they receive
CTX-009 plus PaclitaxelExperimentalNot described
Receives: Drug: CTX-009; Drug: Paclitaxel
PaclitaxelActive 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.
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From randomization to treatment discontinuation for any reason, average 6 months

Secondary outcomes (5)

  1. Progression Free Survival

    Time from randomization until the date of objective PD (as assessed by RECIST 1.1) or the date of death (by any cause in the absence of disease progression)

    Measured: From randomization to first documented objective PD or death if PD does not occur, average 6 months

  2. Duration of Response

    The time between the date of the radiological evaluation that first confirmed CR or PR and the date of the radiation evaluation that first confirmed Progressive Disease (PD)

    Measured: From first confirmed CR or PR to confirmed PD, average 6 months

  3. Overall Survival

    Time from randomization until the date of death by any cause. Patients who are still alive at the time of the analysis, or who have become lost to follow-up or withdrawn consent will be censored at their last date known to be alive

    Measured: From randomization to death from any cause, average 12 months

  4. Disease Control Rate

    Percentage of patients whose BOR is assessed as CR, PR, or Stable Disease (SD)

    Measured: From randomization to treatment discontinuation for any reason, average 6 months

  5. Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities

    Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities for all randomized patients who received at least one dose of study treatment (either CTX-009 or paclitaxel)

    Measured: From randomization to 60 days after the last dose of study treatment, average 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start9 Jan 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05506943
Sponsor's protocol ID
CTX-009-002
Status last verified
Aug 2026
First submitted
15 Aug 2022
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38861293

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CTX-009 and Paclitaxel in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Compass Therapeutics at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response (time frame: From randomization to treatment discontinuation for any reason, average 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05506943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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