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Studie CTX-009 v kombinaci s paklitaxelem u dospělých pacientů s neresekovatelným pokročilým, metastatickým nebo recidivujícím karcinomem žlučových cest

6. listopadu 2026 aktualizováno: Compass Therapeutics

Randomizovaná, kontrolovaná studie fáze 2/3 CTX-009 v kombinaci s paklitaxelem versus samotný paklitaxel u dospělých pacientů s neresekovatelným pokročilým, metastatickým nebo recidivujícím karcinomem žlučových cest, kteří podstoupili jeden předchozí režim systémové chemoterapie

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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

168

Fáze

  • Fáze 2
  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: CTX-009 plus paklitaxel
Lék: CTX-009

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

Lék: Paclitaxel

IV infusion on day 1, 8, and 15 of every 28 day cycle
Aktivní komparátor: 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.
Lék: Paclitaxel

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Best Overall Response
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression Free Survival
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Compass Therapeutics

Vyšetřovatelé

  • Ředitel studie: Cynthia Sirard, MD, Compass Therapeutics

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. ledna 2023

Primární dokončení (Odhadovaný)

31. srpna 2027

Dokončení studie (Odhadovaný)

31. srpna 2027

Termíny zápisu do studia

První předloženo

15. srpna 2022

První předloženo, které splnilo kritéria kontroly kvality

16. srpna 2022

První zveřejněno (Aktuální)

18. srpna 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. listopadu 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CTX-009-002

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Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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