• Eng
  • 中文
  • 日本語
  • Span
  • Eng
  • 中文
  • 日本語
  • Span
メニュー
臨床試験の検索
検索結果に戻る
参加受付中
アステラス試験のID
3082-CL-0101

A study of ASP3082 in adults with advanced solid tumors

アステラス試験のID
NCT05382559
Clinicaltrials.gov ID
NCT05382559
EUCTIS ID
N/A
jRCT ID
jRCT2031220738
CN CDE ID
N/A
詳しい情報の入手

Trial purpose

Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors.

ASP3082 is a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from the treatment.

臨床試験のその他の詳細

臨床試験の相（フェーズ）
第1相（フェーズ1）
製品
ASP3082
製品
  • ASP3082
  • Cetuximab
  • Chemotherapy 1
  • Chemotherapy 2
    • 種類
    Interventional
    盲検化
    None (Open Label)
    登録目標症例数
    541
    臨床試験のその他の詳細を閲覧

    Who May Participate

    People in this study will be adults with locally advanced, unresectable or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. The key reasons people cannot take part are if they have symptomatic or untreated cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomeningeal disease), or they have recently had other active cancers that required treatment.

    For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy.

    What to expect

    This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. This study will be in 2 parts.

    In Part 1, different small groups of people will receive lower to higher doses of either: ASP3082 by itself or ASP3082 together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.

    In Part 2, other different small groups of people will receive: ASP3082 by itself, ASP3082 with cetuximab, ASP3082 with different types of chemotherapy, ASP3082 with pembrolizumab, or ASP3082 with chemotherapy and pembrolizumab. The most suitable doses of ASP3082 worked out from Part 1 will be used.

    Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. People will continue treatment until:

    • they have medical problems from the treatment they can’t tolerate;
    • their cancer gets worse;
    • they start other cancer treatment;
    • or they ask to stop treatment.

    People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. At the clinic visits people will have health checks. Tumor samples will be taken at certain visits during treatment and when treatment has finished.

    People will visit the clinic shortly after stopping treatment for a health check. After this, people will continue to have health checks every couple of months to check the condition of their cancer. They will do this until about 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer treatment, or they ask to stop treatment.

    Timer icon
    Length of study treatment
    Until discontinuation criteria are met
    Coin icon
    Number of study visits
    Varies by participant

    試験の概要

    The main aims (primary objectives)

    • To check the safety of ASP3082 by itself and together with the other study treatments, and how well it is tolerated.
    • To find a suitable dose of ASP3082 by itself and together with the other study treatments.

    Other aims (secondary objectives)

    • To check how ASP3082 is processed by the body (pharmacokinetics, or PK).
    • To check how well ASP3082 controls tumors.

    How the aims are carried out (endpoints)

    • Recording medical problems that happen during the study after receiving ASP3082, whether they were caused by ASP3082 or not. This may include abnormal results from lab tests, medical examinations and electrocardiograms (ECGs).
    • Checking if medical problems or abnormal lab test results that may be caused by ASP3082 are serious enough to stop increasing the dose.
    • Checking blood levels of ASP3082 over time to learn how long it takes to get into the blood, spread through the body and be cleared by the body. Also checking if ASP3082 is broken down by the body.
    • Using scans to check if tumors shrink or disappear over time, after treatment with ASP3082.
    • Checking for changes in KRAS G12D protein levels on tissue samples.

    詳しい情報の入手

    治療歴のある成人の固形がん患者さんを対象としたASP3082の試験の参加者を募集している治験実施医療機関について詳細情報をご希望ですか？右側のフォームに必要事項を入力の上お問合せください。担当者が対応いたします。

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
    • アイスランド
    • アイルランド
    • アルジェリア
    • アルゼンチン
    • アルメニア
    • イスラエル
    • イタリア
    • インド
    • インドネシア
    • ウクライナ
    • エジプト
    • エストニア
    • オーストラリア
    • オーストリア
    • オランダ
    • カザフスタン
    • カナダ
    • ギリシャ
    • グァテマラ
    • クロアチア
    • コロンビア
    • サウジアラビア
    • ジョージア
    • シンガポール
    • スイス
    • スウェーデン
    • スペイン
    • スロバキア
    • スロベニア
    • セルビア
    • タイ
    • チェコ共和国
    • チリ
    • デンマーク
    • ドイツ
    • ドミニカ共和国
    • トルコ
    • ニュージーランド
    • ノルウェー
    • パナマ
    • ハンガリー
    • フィリピン
    • フィンランド
    • プエルトリコ
    • ブラジル
    • フランス
    • ブルガリア
    • ベトナム
    • ベラールス
    • ペルー
    • ベルギー
    • ポーランド
    • ボスニア・ヘルツェゴビナ
    • ポルトガル
    • マケドニア
    • マレーシア
    • メキシコ
    • モルドバ共和国
    • モロッコ
    • モンテネグロ
    • ヨルダン
    • ラトビア
    • リトアニア
    • ルーマニア
    • レバノン
    • ロシア連邦
    • 中国
    • 南アフリカ
    • 台湾、中華民国
    • 大韓民国
    • 日本
    • 旧セルビア・モンテネグロ
    • 米国
    • 英国
    • 香港

    [同意する/送信]をクリックすると、治験実施医療機関に関する情報をアステラスより電子メールでお送りすることについて同意されたものとみなされます。治験実施医療機関についてご案内していますが、開発中の治療に関するご質問に、アステラスから電子メールで回答することはできません。電子メールの受信に同意することは、臨床試験または研究に参加するための要件ではありません。アステラスからの情報の配信を停止する方法等の詳細については、当社のプライバシー通知を参照してください。 プライバシーポリシーおよびクッキーポリシー.

      場所

      お問い合わせ
      お問い合わせ
      参加受付中
      NEXT Oncology
      San Antonio, Texas, 米国, 78229
      お問い合わせ
      参加受付中
      SCRI Oncology Partners
      Nashville, Tennessee, 米国, 37203
      お問い合わせ
      参加受付中
      Columbia University - Herbert Irving Comprehensive Cancer Center
      New York, New York, 米国, 10032
      お問い合わせ
      参加受付中
      Florida Cancer Specialists & Research Institute Sarasota
      Sarasota, Florida, 米国, 34232-6422
      お問い合わせ
      参加受付中
      NEXT Oncology - Virginia Cancer Specialists
      Fairfax, Virginia, 米国, 22031
      お問い合わせ
      参加受付中
      Memorial Sloan Kettering Cancer Center
      New York, New York, 米国, 10065
      お問い合わせ
      参加受付中
      UCLA Santa Monica Hematology Oncology
      Santa Monica, California, 米国, 90404
      お問い合わせ
      参加受付中
      University of Kansas Medical Center
      Westwood, Kansas, 米国, 66205
      お問い合わせ
      参加受付中
      Vanderbilt University Medical Center
      Nashville, Tennessee, 米国, 37232
      お問い合わせ
      参加受付中
      Smilow Cancer Center at Yale New Haven Hospital
      New Haven, Connecticut, 米国, 06520-8028
      お問い合わせ
      参加受付中
      Washington University School of Medicine
      St. Louis, Missouri, 米国, 63110
      お問い合わせ
      参加受付中
      Dana Farber Cancer Institute
      Boston, MA, 米国, 02215
      お問い合わせ
      参加受付中
      Cancer Institute Hospital of JFCR
      Koto-ku, Tokyo, 日本
      お問い合わせ
      参加受付中
      National Cancer Center Hospital
      Chuo-ku, Tokyo, 日本
      お問い合わせ
      参加受付中
      National Cancer Center Hospital East
      Kashiwa, Chiba, 日本
      お問い合わせ
      参加受付中
      Roswell Park Cancer Institute
      Buffalo, NY, 米国, 14263
      お問い合わせ
      参加受付中
      Kindai University Hospital
      Osakasayama, Osaka, 日本
      お問い合わせ
      参加受付中
      Shizuoka Cancer Center
      Sunto-gun, Shizuoka, 日本
      お問い合わせ
      参加受付中
      Gustave Roussy
      Villejuif, Île-de-France, フランス
      お問い合わせ
      治験情報
      治験をフォローする
      年齢
      18+ years
      疾患等
    • 進行性または転移性がん
      • 性別
      女性・男性
      試験期間
      Jun 2022 - Oct 2026
      臨床試験のその他の詳細
      組み入れ基準
      • Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive or has refused standard approved therapies (no limit to the number of prior treatment regimens).
      • For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled.
      • Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but not more than 56 days prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor/study medical monitor.
      • Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
      • Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
      • Participant’s last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.
      • Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent [defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone] is permitted), and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<= 2 weeks of radiotherapy) to non-central nervous system disease.
      • Participant’s adverse events [AEs] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention.
      • Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained >= 14 days after any blood transfusion.).
      • Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
        • Not a woman of childbearing potential (WOCBP).
        • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.
      • Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after study intervention administration.
      • Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after study intervention administration.
      • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 3 months after study intervention administration.
      • Male participant must not donate sperm during the treatment period and for 3 months after study intervention administration.
      • Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 3 months after study intervention administration.
      • Participant agrees not to participate in another interventional study while receiving study intervention (Participants who are currently in the follow-up period of an interventional clinical trial are allowed).
      除外基準
      • Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.
      • Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.
      • Participant has leptomeningeal disease as a manifestation of the current malignancy.
      • Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
      • Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
      • Participant with active hepatitis B (including acute hepatitis B virus [HBV] or chronic HBV) or hepatitis C virus [HCV] (ribonucleic acid [RNA] detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.
      • Participant has a known history of human immunodeficiency virus [HIV] infection. No HIV testing is required unless mandated by a local health authority.
      • Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) < 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome.
      • Participant has a corrected QT interval (single electrocardiogram [ECG]) using Fridericia’s formula (QTcF) > 450 milliseconds (msec) (men) or >470 msec (women) during screening.
      • Participant has received prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor/degrader are eligible for the ASP3082 combination therapy cohort.
      • Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
      • Participant is expected to require another form of antineoplastic therapy while on study treatment.
      • Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness/social situations that would limit compliance with study requirements).
      • Participant has known history of COVID-19 positive polymerase chain reaction (PCR) test within 4 weeks prior to the start of study treatment.
      • Participant has had major surgery within 4 weeks prior to first dose of study intervention.

        • For ASP3082 Combination Therapy:

      • Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.
      • History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.

      よくあるご質問

      臨床試験は進行がんの人だけが対象ですか。

      一部の臨床試験は進行がんを対象としていますが、さまざまな病期の患者さんが参加できる臨床試験も数多くあります。それぞれの試験には一定の参加条件があります。たとえば特定の年齢層や腫瘍の種類の患者さんだけが参加できる場合もあります。

      臨床試験に参加するために、現在の治療をやめる必要がありますか。

      臨床試験によっては、現在受けている治療を続けたまま参加できる場合もあれば、一時的に中止しなければならない場合もあります。もし治験薬で効果がみられなかった場合でも、通常は元の治療を再開することができます。

      プラセボが割り当てられるのを心配すべきですか。

      がんの臨床試験でプラセボが使われるのは、特定のがんに利用できる治療が存在しない場合に限られ、治験薬とプラセボを比較するためにだけ使用されます。ただし、がんの臨床試験でプラセボが使われることはまれで、多くの場合は「標準治療」と呼ばれる最も有効とされる治療が提供されます。

      臨床試験に参加するには、主治医からの紹介状が必要ですか。

      担当医が、あなたに利用可能な臨床試験の機会をすべて把握していない場合があります。気になる臨床試験があった場合は、ぜひ担当医や他の医療提供者にご相談ください。あなたに合った臨床試験かどうかを、一緒に判断することができます。このウェブサイトで選択肢が見つからない場合は、公的な治験情報登録サイト（例： ClinicalTrials.gov ）をご覧になり、現在募集中の臨床試験を探してみることをお勧めいたします。

      詳細

      1

      臨床試験とは何か

      臨床試験を探す
      2

      臨床試験が重要である理由

      詳細
      3

      臨床試験に参加する理由

      さらに知る