再発/耐衝撃性の小細胞肺がんの中国人参加者におけるBMS-986489の安全性、忍容性、薬物動態、および予備的有効性を評価するための研究
安全性、忍容性、薬物動態、および予備的有効性を評価するためのオープンラベル、シングルアーム、マルチセンター、フェーズ1研究。癌
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究場所
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Shanghai、中国、200120
- Local Institution - 0002
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100142
- Local Institution - 0004
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Shandong
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Jinan、Shandong、中国、250117
- Local Institution - 0003
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Linyi、Shandong、中国、276001
- Local Institution - 0001
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Zhejiang
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Hangzhou、Zhejiang、中国、310016
- Local Institution - 0005
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-
参加基準
適格基準
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:
- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
i) For initial limited stage (LS) SCLC:.
A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- Participants must have a life expectancy of ≥12 weeks.
- Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
- Untreated symptomatic CNS metastases.
- Leptomeningeal disease.
- Pleural effusion which cannot be controlled with appropriate interventions.
- Malignancy-related superior vena cava syndrome.
- Participants with an active, known or suspected, autoimmune disease.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- Unresolved toxicity from prior anti-tumor therapy.
- Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
- Other protocol-defined inclusion/exclusion criteria apply.
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:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的:BMS-986489
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Specified dose on specified days |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of participants with adverse events (AEs)
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
|
Number of participants with Serious AEs (SAEs)
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with AEs leading to discontinuation of study treatment
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with select AEs
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with immune-mediated AEs (IMAEs)
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of deaths
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with laboratory abnormalities
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Maximum observed concentration (Cmax) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
|
Time of maximum observed concentration (Tmax) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Trough observed plasma concentration (Ctrough) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Concentration at the end of a dosing interval (Ctau) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
|
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Total body clearance (CLT) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
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Observed concentration at end of infusion (Ceoi) for BMS-986012
時間枠:Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
二次結果の測定
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-drug antibodies (ADAs) to BMS-986012
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with ADAs to nivolumab
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ctrough for nivolumab
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ceoi for nivolumab
時間枠:Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Overall Response (OR)
時間枠:Up to 19 months after last participant's first treatment
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Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
|
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Disease Control (DC)
時間枠:Up to 19 months after last participant's first treatment
|
Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
|
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Duration of Response (DOR)
時間枠:Up to 19 months after last participant's first treatment
|
Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. |
Up to 19 months after last participant's first treatment
|
協力者と研究者
捜査官
捜査官
- スタディディレクター:Bristol-Myers Squibb、Bristol-Myers Squibb
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CA245-0002
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
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD 共有時間枠
See Plan Description
IPD 共有アクセス基準
See Plan Description
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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
米国で製造され、米国から輸出された製品。
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。