進行性固形悪性腫瘍の治療のためのアミバンタマブ皮下（SC）投与の研究 (PALOMA)
進行性固形悪性腫瘍の治療のためのアミバンタマブ、ヒト二重特異性 EGFR および cMet 抗体の皮下送達の安全性および薬物動態を評価するための非盲検、多施設、用量漸増第 1b 相試験
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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West Hollywood、California、アメリカ、90048
- Cedars Sinai Medical Center
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Indiana
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Indianapolis、Indiana、アメリカ、46256
- Community Health Network
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New York
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New York、New York、アメリカ、10016
- Langone Health at NYC University, NYU School of Medicine
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Oregon
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Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute
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Manchester、イギリス、M20 4BX
- The Christie Nhs Foundation Trust
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Sutton、イギリス、SM2 5PT
- Royal Marsden Hospital
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Ontario
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Toronto、Ontario、カナダ、M5G 2M9
- University Health Network
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Cheongju-si、韓国、28644
- Chungbuk National University Hospital
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Seongnam-si、韓国、13620
- Seoul National University Bundang Hospital
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Seoul、韓国、03722
- Severance Hospital Yonsei University Health System
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Seoul、韓国、06351
- Samsung Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy. Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), renal cell cancer (RCC), medullary thyroid cancer (MTC), gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). Participants must have either progressed after prior standard of care therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
- A man who is sexually active with a woman of childbearing potential must agree to use a condom and his partner must also be practicing a highly effective method of contraception (that is, established use of oral, injected or implanted hormonal methods of contraception; placement of an Intrauterine device [IUD] or Intrauterine system [IUS])
Exclusion criteria:
- Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), diagnosed or suspected viral infection (except Human immunodeficiency virus [HIV] positive participants with 1 or more of the following: a) not receiving highly active antiretroviral therapy; b) a change in antiretroviral therapy within 6 months of the start of screening; c) cluster of differentiation 4 (CD4)+ T-cell count less than [<]350 per cubic millimeters [mm^3] at screening; d) an acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening), or psychiatric illness/social situation that would limit compliance with study requirements, including ability to self-care for anticipated toxicities [that is. rash or paronychia]. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded
- Participant has had prior chemotherapy, targeted cancer therapy, or treatment with an investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug; or participant has received prior immunotherapy within 6 weeks before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2 hypothyroidism stable on hormone replacement). Autoimmune toxicities from previous immunotherapy must be fully resolved to baseline levels
- Participants with untreated brain metastases. Participants with locally treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (<=10 milligrams [mg] prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible
- Participant has an active malignancy other than the disease under study requiring treatment
- Participant has leptomeningeal disease
研究計画
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Part 1: Ami-LC-MD and Ami-LC
Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion. |
Participants will receive amivantamab admixed with rHuPH20 SC infusion. Participants will receive amivantamab SC infusion. |
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実験的：Part 2: Ami-HC and Ami-HC-CF
Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF). |
Participants will receive amivantamab SC infusion. Participants will receive amivantamab co-formulated with rHuPH20 as SC injection. |
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 |
|---|---|---|
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Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
時間枠：Up to Day 29
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Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration. |
Up to Day 29
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Number of Participants with Adverse Event (AE)
時間枠：Up to 4 years 1 month
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An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. |
Up to 4 years 1 month
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Number of Participants with Dose Limiting Toxicity (DLT)
時間枠：Up to Day 28
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Number of participants with DLT will be assessed. |
Up to Day 28
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Number of Participants with Clinical Laboratory Abnormalities
時間枠：Up to 4 years 1 month
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Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed. |
Up to 4 years 1 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
時間枠：Up to 4 years 1 month
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Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed. |
Up to 4 years 1 month
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Epidermal Growth Factor Receptor (EGFR) Concentrations
時間枠：Up to 4 years 1 month
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EGRF concentrations markers will be assessed. |
Up to 4 years 1 month
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Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
時間枠：Up to 4 years 1 month
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cMET markers will be analyzed. |
Up to 4 years 1 month
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Overall Response Rate (ORR)
時間枠：Up to 4 years 1 month
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ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1. |
Up to 4 years 1 month
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Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State
時間枠：Up to 4 years 1 month
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Maximum amivantamab dosing interval Between time zero to steady state will be assessed. |
Up to 4 years 1 month
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協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CR108891
- 2020-003225-36 (EudraCT番号)
- 61186372NSC1003 (その他の識別子：Janssen Research & Development, LLC)
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?
IPD プランの説明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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
米国FDA規制機器製品の研究
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。