A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
2026年9月2日 更新者:MediLink Therapeutics (Suzhou) Co., Ltd.
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
The purpose of this study is to evaluate the safety and efficacy of an investigational B7-H3 antibody drug-conjugate administered as monotherapy, compared with standard of care (SOC) chemotherapy in metastatic pancreatic cancer patients who have failed prior Gemcitabine-based systemic therapy.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
320
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:MediLink Study Team
- 電話番号:+86 512 62858368
- メール:clinicaltrials@medilinkthera.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200127
- Shanghai Jiaotong University School of Medicine
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コンタクト:
- Study Coordinator
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study.
- Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study.
- Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases.
- Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks.
- Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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: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:Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
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Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
他の名前:
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アクティブコンパレータ:Chemotherapy
Active comparator: nal-IRI+5-FU/LV
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Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. 5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. |
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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PFS by BICR
時間枠:Up to approximately 2 years
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Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
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Up to approximately 2 years
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OS
時間枠:Up to approximately 2 years
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OS is defined as the time from randomization until death from any cause.
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Up to approximately 2 years
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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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PFS by investigator
時間枠:Up to approximately 2 year
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PFS per RECIST v1.1, as assessed by Investigator
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Up to approximately 2 year
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ORR
時間枠:Up to approximately 2 years
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Objective Response Rate (ORR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DCR
時間枠:Up to approximately 2 years
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Disease Control Rate (DCR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DoR
時間枠:Up to approximately 2 years
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Duration of Response (DoR), as assessed by BICR and Investigator
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Up to approximately 2 years
|
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TTR
時間枠:Up to approximately 2 years
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Time to Response (TTR), as assessed by BICR and Investigator
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Up to approximately 2 years
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Adverse Event
時間枠:Up to approximately 2 years
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The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
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Up to approximately 2 years
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To evaluate the AUC
時間枠:Up to approximately 2 years
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Up to approximately 2 years
|
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To evaluate the Cmax
時間枠:Up to approximately 2 years
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Up to approximately 2 years
|
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To evaluate the Ctrough
時間枠:Up to approximately 2 years
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Up to approximately 2 years
|
|
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To evaluate the CL
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
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To evaluate the Vd
時間枠:Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the t1/2
時間枠:Up to approximately 2 years
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Up to approximately 2 years
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Immunogenicity
時間枠:Up to approximately 2 years
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Incidence of anti-drug antibodies of YL201
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Up to approximately 2 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年1月1日
研究の完了 (推定)
2029年5月1日
試験登録日
最初に提出
2026年8月31日
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
2026年9月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年9月1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
- TAISHAN-305
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
いいえ
米国FDA規制機器製品の研究
いいえ
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