転移性結腸直腸癌に対するJNJ-89402638の研究
切除不能な転移性結腸直腸がんを対象としたJNJ-89402638の第I相試験
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85719
- 募集
- University of Arizona Cancer Center
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Colorado
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Aurora、Colorado、アメリカ、80045
- 募集
- University of Colorado Denver Anschultz Medical Campus
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Florida
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Sarasota、Florida、アメリカ、34232
- 募集
- Florida Cancer Specialists
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Indiana
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Indianapolis、Indiana、アメリカ、46256
- 募集
- Community Health Network
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Michigan
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Grand Rapids、Michigan、アメリカ、49546
- 募集
- Start Midwest
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Washington
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Seattle、Washington、アメリカ、98104
- 募集
- Swedish Cancer Institute
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Barcelona、スペイン、08035
- 募集
- Hosp Univ Vall D Hebron
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Madrid、スペイン、28041
- 募集
- Hosp. Univ. 12 de Octubre
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Madrid、スペイン、28040
- 募集
- Hosp Univ Fund Jimenez Diaz
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Madrid、スペイン、28050
- 募集
- Hosp Univ Hm Sanchinarro
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Seoul、韓国、05505
- 募集
- Asan Medical Center
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Seoul、韓国、03722
- 募集
- Severance Hospital Yonsei University Health System
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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:
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For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
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Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- Part 2: Must have at least 1 measurable lesion
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
Exclusion Criteria:
- Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
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：順次割り当て
- 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 (Dose Expansion)
Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified. |
JNJ-89402638 will be administered. |
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実験的：Part 2 (Dose Expansion): Arm A
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy. |
JNJ-89402638 will be administered. |
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実験的：Part 2 (Dose Expansion): Arm B
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. |
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実験的：Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. Chemotherapy agent FOLFOX will be administered. |
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実験的：Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. Chemotherapy agent FOLFIRI will be administered. |
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実験的：Part 2 (Dose Expansion): Arm E
Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1. |
JNJ-89402638 will be administered. |
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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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
時間枠：From Baseline up to approximately 24 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus. |
From Baseline up to approximately 24 months
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
時間枠：From Baseline up to 28 days
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The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities. |
From Baseline up to 28 days
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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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Part 1 and Part 2: Serum Concentration for JNJ-89402638
時間枠：Up to approximately 24 months
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Serum Concentration for JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
時間枠：Up to approximately 24 months
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Cmax of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
時間枠：Up to approximately 24 months
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Cmin of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
時間枠：Up to approximately 24 months
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Tmax of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
時間枠：Up to approximately 24 months
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AUC of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
時間枠：Up to approximately 24 months
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Participants with anti-JNJ-89402638 antibodies will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Overall Response (OR)
時間枠：Up to approximately 24 months
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Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Complete Response (CR)
時間枠：Up to approximately 24 months
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Complete response is defined as a best response of CR assessed according to RECIST version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Time to Response (TTR)
時間枠：Up to approximately 24 months
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TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Duration of Response (DOR)
時間枠：Up to approximately 24 months
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DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1 |
Up to approximately 24 months
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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 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 89402638GIC1001
- 2024-516526-66-00 (レジストリ識別子：EUCT number)
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 www.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。