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切除不能な進行性、転移性または再発性胆道癌の成人患者における CTX-009 とパクリタキセルの併用に関する研究

2026年11月4日 更新者：Compass Therapeutics

切除不能な進行性、転移性または再発性胆道がんの成人患者で、以前に全身化学療法レジメンを 1 回受けた CTX-009 とパクリタキセルの併用とパクリタキセル単独の第 2/3 相ランダム化比較試験

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

168

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：CTX-009 プラス パクリタキセル
薬：CTX-009

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

薬：Paclitaxel

IV infusion on day 1, 8, and 15 of every 28 day cycle
アクティブコンパレータ：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.
薬：Paclitaxel

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Best Overall Response
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Compass Therapeutics

捜査官

  • スタディディレクター：Cynthia Sirard, MD、Compass Therapeutics

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年1月9日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2022年8月15日

QC基準を満たした最初の提出物

2022年8月16日

最初の投稿 (実際)

2022年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CTX-009-002

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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