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Badanie CTX-009 w skojarzeniu z paklitakselem u dorosłych pacjentów z nieoperacyjnym zaawansowanym, przerzutowym lub nawracającym rakiem dróg żółciowych

6 listopada 2026 zaktualizowane przez: Compass Therapeutics

Randomizowane, kontrolowane badanie fazy 2/3 dotyczące stosowania CTX-009 w skojarzeniu z paklitakselem w porównaniu z samym paklitakselem u dorosłych pacjentów z nieoperacyjnym zaawansowanym, przerzutowym lub nawracającym rakiem dróg żółciowych, którzy otrzymali jeden wcześniej schemat chemioterapii ogólnoustrojowej

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

168

Faza

  • Faza 2
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85054
        • Mayo Clinic Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85724-5024
        • University of Arizona
    • California
      • Los Angeles, California, Stany Zjednoczone, 90033
        • University of Southern California Norris Comprehensive Cancer Center
      • Palo Alto, California, Stany Zjednoczone, 94305
        • Stanford Medicine Cancer Center
      • San Francisco, California, Stany Zjednoczone, 94143-1770
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80012
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Gainesville, Florida, Stany Zjednoczone, 32611
        • University of Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32224
        • Mayo Clinic Jacksonville
      • Orlando, Florida, Stany Zjednoczone, 32804
        • AdventHealth Orlando
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60611
        • Northwestern University
      • Chicago, Illinois, Stany Zjednoczone, 60637
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02141
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic Rochester
    • Missouri
      • St Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University School of Medicine, Siteman Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, Stany Zjednoczone, 08854
        • Rutgers Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87131
        • The University of New Mexico
      • Las Cruces, New Mexico, Stany Zjednoczone, 88011
        • Memorial Medical Center
    • New York
      • Buffalo, New York, Stany Zjednoczone, 14263
        • Roswell Park
      • New York, New York, Stany Zjednoczone, 10032
        • Columbia University
      • The Bronx, New York, Stany Zjednoczone, 10461
        • Montefiore Medical Center
    • Ohio
      • Canton, Ohio, Stany Zjednoczone, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, Stany Zjednoczone, 44195
        • Cleveland Clinic
    • Tennessee
      • Knoxville, Tennessee, Stany Zjednoczone, 37920
        • University of Tennessee Medical Center
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • SCRI Oncology Partners
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78705
        • Texas Oncology - Austin
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Denison, Texas, Stany Zjednoczone, 75020
        • Texas Oncology - Dension
      • Houston, Texas, Stany Zjednoczone, 77030
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, Stany Zjednoczone, 78217
        • Texas Oncology - San Antonio
      • Tyler, Texas, Stany Zjednoczone, 75702
        • Texas Oncology - Northeast Texas
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98101
        • Virginia Mason Franciscan Health
      • Vancouver, Washington, Stany Zjednoczone, 98684
        • Northwest Cancer Specialists, P.C.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

INCLUSION CRITERIA

  1. 18 years of age or older

  2. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)

  3. 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.

    1. Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor.
    2. Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor.

  4. At least one lesion measurable as defined by RECIST v1.1

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

  6. Predicted life expectancy of at least 12 weeks

  7. No evidence of ongoing infection and adequate biliary excretion or patients whose adequate biliary excretion can be confirmed with the following procedures:

    1. Patients who underwent endoscopic retrograde biliary drainage (ERBD) at least 1 week before the investigational drug treatment
    2. Patients with endobiliary stents are eligible, provided there is no evidence of obstruction
    3. Patients free of any signs of active or suspected uncontrolled infection after a drainage procedure
    4. Patients free of any risk of hemorrhage and with incision completely healed

  8. 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):

    1. Absolute neutrophil count (ANC) ≥ 1,500/mm3
    2. Hemoglobin ≥ 9.0 g/dL
    3. Platelet count ≥ 100,000/mm3
    4. Total bilirubin ≤ 1.5 X ULN
    5. AST/ALT ≤ 3.0 X ULN (≤5 X ULN in case of hepatic metastasis)
    6. Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault
    7. 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.)
    8. Serum amylase and lipase level ≤ 3X ULN
    9. Serum Albumin ≥ 3.0 g/dL

  9. 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

  10. 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.

  11. 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

  1. 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.

  2. From the time point of screening,

    1. Less than 4 weeks have elapsed since patients had a surgery or major procedure
    2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy

  3. Patients with percutaneous transhepatic biliary drains (PTBD)

  4. Prior to the initial treatment of study drug,

    1. Less than 2 weeks have elapsed since patients had chemotherapy or hormone therapy
    2. Less than 2 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
    3. Less than 4 weeks since cryotherapy, radiofrequency ablation, anhydrous alcohol therapy, or photodynamic therapy, including TACE and TARE

  5. A history of the following cardiovascular diseases (please, consult the Sponsor Medical Monitor for a case by case evaluation):

    1. 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)
    2. 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)
    3. Patients with any history of hypertensive crisis or pre-existing hypertensive encephalopathy
    4. Pulmonary hypertension
    5. Myocardial infarction
    6. Uncontrolled arrhythmia
    7. Unstable angina
    8. 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

  6. 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

  7. Patients with contraindications to paclitaxel therapy

  8. 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

  9. 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)

  10. A history of the following hemorrhage-related or gastroenterological disease:

    1. Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor in great arteries
    2. 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)

  11. 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.

    a. 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

  12. 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.

  13. Severe infection requiring ongoing systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases

  14. 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.

  15. 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:

    1. Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening
    2. Major, unhealed injury, active ulcer, or untreated fracture
    3. Pre-existing conditions of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening.
    4. 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.
    5. Interstitial lung disease or pulmonary fibrosis

  16. Patients expected to require anticancer treatment other than the investigational product during the clinical study

  17. Pregnant or lactating patients, or patients planning to become pregnant during the clinical study

  18. 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.

  19. Clinically significant abnormal ECG findings or history determined as clinically significant by the Investigator

  20. QT interval (Fridericia's formula) (QTcF) interval > 450msec at the time of screening

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: CTX-009 plus paklitaksel
Lek: CTX-009

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

Lek: Paclitaxel

IV infusion on day 1, 8, and 15 of every 28 day cycle
Aktywny komparator: Paclitaxel

Patients 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.
Lek: Paclitaxel

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Best Overall Response
Ramy czasowe: From randomization to treatment discontinuation for any reason, average 6 months

Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions.
From randomization to treatment discontinuation for any reason, average 6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival
Ramy czasowe: From randomization to first documented objective PD or death if PD does not occur, average 6 months

Time from randomization until the date of objective PD or the date of death (by any cause in the absence of disease progression). Progression of diseases is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From randomization to first documented objective PD or death if PD does not occur, average 6 months
Duration of Response
Ramy czasowe: From first confirmed CR or PR to confirmed PD, average 6 months

Time from the CT or MRI that first confirmed complete (CR) or partial response PR) to the CT or MRI that first confirmed progression of disease progression (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; PD = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first confirmed CR or PR to confirmed PD, average 6 months
Overall Survival
Ramy czasowe: From randomization to death from any cause, average 12 months

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
From randomization to death from any cause, average 12 months
Disease Control Rate
Ramy czasowe: From randomization to treatment discontinuation for any reason, average 6 months

Percentage of all treated patients whose best overall response was complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
From randomization to treatment discontinuation for any reason, average 6 months
Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities
Ramy czasowe: From the first dose of either study drug to 30 days after the last dose of study treatment, average 7 months

TEAE is defined by occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-009 or paclitaxel through 30 days after the last dose of CTX-009 or paclitaxel. Change in clinical abnormalities is defined as an increase in abnormality grade in a laboratory result, vital sign, or ECG parameter from predose result to worst postdose result (graded according to the Common Terminology Criteria for Adverse Events v5.0 for all analytes except for brain natriuretic peptide and troponin subtypes, which are interpreted in reference to the laboratory reference range for each), a post-baseline potentially clinically significant vital sign abnormality, or a post-baseline potentially clinically significant ECG abnormality.
From the first dose of either study drug to 30 days after the last dose of study treatment, average 7 months
Efficacy of CTX-009 in combination with paclitaxel in patients who crossed over from the paclitaxel only arm
Ramy czasowe: From the first dose of CTX-009 following crossover to the subsequent radiographic progression confirmed by the ICR or death, whichever occurs first

Evaluation of ORR, DCR and progression free survival 2 (PFS2) in the crossover set (COS). PFS2 is defined as the time from the first dose of CTX-009 following crossover to the subsequent radiographic progression confirmed by the ICR or death, whichever occurs first
From the first dose of CTX-009 following crossover to the subsequent radiographic progression confirmed by the ICR or death, whichever occurs first
Quality of Life (QoL)
Ramy czasowe: From randomization to treatment discontinuation for any reason, average 6 months

Changes in QoL scores, as measured using the EORTC QLQ-C30 and BIL21, from baseline in patients treated with CTX-009 in combination with paclitaxel vs. paclitaxel alone
From randomization to treatment discontinuation for any reason, average 6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Compass Therapeutics

Śledczy

  • Dyrektor Studium: Cynthia Sirard, MD, Compass Therapeutics

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 stycznia 2023

Zakończenie podstawowe (Szacowany)

31 sierpnia 2027

Ukończenie studiów (Szacowany)

31 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

15 sierpnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 sierpnia 2022

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CTX-009-002

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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