進行性固形腫瘍を有する成人におけるBG-C0979の初回ヒト試験
選択された進行性固形癌患者におけるBG-C0979の安全性、忍容性、薬物動態、および予備的抗腫瘍活性を検討する多施設共同、非盲検、第1a/b相ファーストインヒューマン試験
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
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 Director
- 電話番号：8778285568
- メール：clinicaltrials@beonemed.com
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215-5418
- 募集
- Dana Farber Cancer Institute
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Missouri
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St Louis、Missouri、アメリカ、63110-1010
- 募集
- Washington University School of Medicine
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- 募集
- John Theurer Cancer Center Hackensack University Medical Center
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Texas
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San Antonio、Texas、アメリカ、78229
- 募集
- Next Oncology San Antonio
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New South Wales
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Frenchs Forest、New South Wales、オーストラリア、NSW 2086
- 募集
- Northern Beaches Hospital
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Liverpool、New South Wales、オーストラリア、NSW 2170
- 募集
- Liverpool Hospital
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Queensland
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South Brisbane、Queensland、オーストラリア、QLD 4101
- 募集
- Icon Cancer Centre South Brisbane
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Victoria
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Malvern、Victoria、オーストラリア、VIC 3144
- 募集
- Cabrini Hospital Malvern
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Barcelona、スペイン、08036
- 募集
- Hospital Clinic de Barcelona
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Barcelona、スペイン、08035
- 募集
- Hospital Universitario Vall Dhebron
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Madrid、スペイン、28040
- 募集
- Hospital Universitario Fundacion Jimenez Diaz
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Madrid、スペイン、28223
- 募集
- Next Oncology Madrid
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100021
- 募集
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400037
- 募集
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
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Fujian
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Fuzhou、Fujian、中国、350028
- 募集
- Mengchao Hepatobiliary Hospital of Fujian Medical University
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Guangdong
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Guangzhou、Guangdong、中国、510245
- 募集
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Hubei
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Yichang、Hubei、中国、443003
- 募集
- Yichang Central Peoples Hospital
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、201321
- 募集
- Fudan University Shanghai Cancer Centerpudong
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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:
- Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria:
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol defined Inclusion/Exclusion criteria may 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：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：Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy. |
Administered by intravenous infusion. |
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実験的：Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
Administered by intravenous infusion. |
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実験的：Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
Administered by intravenous infusion. |
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実験的：Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Administered by intravenous infusion. Administered by intravenous infusion.
他の名前：
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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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Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
時間枠：Up to approximately 24 months
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
時間枠：Up to approximately 10 months
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MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively. |
Up to approximately 10 months
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Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
時間枠：Up to approximately 10 months
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The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available. |
Up to approximately 10 months
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Phase 1b: Recommended Phase 2 Dose (RP2D)
時間枠：Up to approximately 24 months
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RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available. |
Up to approximately 24 months
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Phase 1b: Overall Response Rate (ORR)
時間枠：Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
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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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第1a相：BG-C0979の血漿中濃度
時間枠：最大約3ヶ月
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最大約3ヶ月
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第1a相：BG-C0979の血中濃度-時間曲線下面積（AUC）
時間枠：最大約3ヶ月
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最大約3ヶ月
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Phase 1a：BG-C0979の最大観察濃度（Cmax）
時間枠：約3か月まで
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約3か月まで
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第1a相：BG-C0979の最高血中濃度到達時間（Tmax）
時間枠：約3ヶ月まで
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約3ヶ月まで
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第1b相：BG-C0979単独およびティセリリズマブとの併用時の血漿中濃度
時間枠：最大約3ヶ月
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最大約3ヶ月
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Phase 1a: ORR
時間枠：Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
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Phase 1a and 1b: Duration of Response (DOR)
時間枠：Up to approximately 24 months
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DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
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Phase 1a and 1b: Disease Control Rate (DCR)
時間枠：Up to approximately 24 months
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DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease. |
Up to approximately 24 months
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Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
時間枠：Up to approximately 24 months
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Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
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Phase 1b: Progression-Free Survival
時間枠：Up to approximately 24 months
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PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
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Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
時間枠：Up to approximately 24 months
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rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
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Prostate-Specific Antigen (PSA) Response for Participants with CRPC
時間枠：Up to approximately 24 months
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PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
Up to approximately 24 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Study Director、BeOne Medicines
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
- BG-C0979-101
- 2025-524857-15-00 (Ctis)
- CTR20261327 (その他の識別子：ChinaDrugTrials)
- 2025 (米国 NIH グラント/契約)
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
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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
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