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局所進行性または転移性固形腫瘍を有する被験者におけるHER3-DXdの研究

2026年10月23日 更新者：Daiichi Sankyo

HERTHENA-PanTumor01 (U31402-277): 局所進行性または転移性固形腫瘍を有する被験者におけるパトリツマブ デルクステカン (HER3-DXd; U3-1402) の第 2 相、多施設共同、マルチコホート、非盲検、概念実証研究

This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma [cutaneous/acral], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced unresectable or metastatic solid tumors who have been previously treated with ≥1 prior line of systemic anticancer therapy.

The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. Secondary objectives include the assessment of safety and tolerability, efficacy, and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated.

研究の種類

介入

入学 (推定)

740

段階

  • フェーズ2

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：Daiichi Sankyo Contact for Clinical Trial Information
  • 電話番号：9089926400
  • メール：CTRinfo@dsi.com

研究場所

  • アメリカ
    • California
      • Duarte、California、アメリカ、91010
        • 募集
        • City of Hope
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • 募集
        • Yale Cancer Center
    • Florida
      • Kissimmee、Florida、アメリカ、34747
        • 募集
        • AdventHealth Medical Group Oncology Research at Celebration
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • 募集
        • University of Illinois Cancer Center
    • Maryland
      • Baltimore、Maryland、アメリカ、21205
        • 募集
        • Johns Hopkins University
      • Rockville、Maryland、アメリカ、20850
        • 募集
        • Maryland Oncology Hematology, PA
    • Minnesota
      • Saint Louis Park、Minnesota、アメリカ、55426
        • 募集
        • Health Partners Frauenshuh Cancer Center
      • Saint Paul、Minnesota、アメリカ、55101
        • 募集
        • Health Partners Cancer Center at Regions Hospital
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • 募集
        • Washington University, School of Medicine
    • New York
      • Buffalo、New York、アメリカ、14203
        • 募集
        • Roswell Park Cancer Institute IDS
      • New York、New York、アメリカ、10065
        • 募集
        • Memorial Sloan Kettering Hospital
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • SCRI Oncology Partners
    • Texas
      • Houston、Texas、アメリカ、77030
        • 募集
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 完了
        • Fred Hutchinson Cancer Center
  • イギリス
      • Cambridge、イギリス、CB2 0QQ
        • 募集
        • Addenbrooke's Hospital
      • Coventry、イギリス、CV2 2DX
        • 募集
        • University Hospital Coventry
      • London、イギリス、NW3 2QG
        • 募集
        • Royal Free Hospital
      • London、イギリス、EC1A 7BE
        • 募集
        • Barts Hospital
      • Nottingham、イギリス、NG5 1PB
        • 募集
        • Nottingham City Hospital Campus
  • イタリア
      • Bergamo、イタリア、24125
        • 募集
        • Humanitas Gavazzeni
      • Genova、イタリア、16132
        • 募集
        • IRCCS Ospedale Policlinico San Martino
      • Naples、イタリア、80131
        • 募集
        • AOU Federico II - Oncologia Clinica
      • Verona、イタリア、37134
        • 募集
        • Centro Ricerche Cliniche di Verona s.r.l.
  • オランダ
      • Amsterdam、オランダ、1081 HV
        • 募集
        • Amsterdam UMC locatie Vumc
      • Groningen、オランダ、9713 GZ
        • 募集
        • Universitair Medisch Centrum Groningen
      • Leiden、オランダ、2333 ZG
        • 募集
        • Leids Universitair Medisch Centrum
      • Maastricht、オランダ、6229 HX
        • 募集
        • Maastricht University Medical Center
      • Nijmegen、オランダ、6525 GA
        • 募集
        • Radboud University Medical Center
  • オーストラリア
      • Camperdown、オーストラリア、2050
        • 募集
        • Chris O'Brien Lifehouse
      • Chermside、オーストラリア、4032
        • 募集
        • Icon Cancer Centre Chermside
      • Clayton、オーストラリア、3168
        • 募集
        • Monash Medical Centre Clayton
      • Hobart、オーストラリア、7000
        • 募集
        • Icon Cancer Centre Hobart
      • Hyde Park、オーストラリア、4812
        • 募集
        • Icon Cancer Centre Townsville
  • カナダ
      • Toronto、カナダ、M4N 3M5
        • 募集
        • Sunnybrook Research Institute
      • Toronto、カナダ、M5G2M9
        • 完了
        • Princess Margaret Cancer Centre
      • Vancouver、カナダ、V5Z4E6
        • 募集
        • BC Cancer - Vancouver
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • 募集
        • Cross Cancer Institute
  • スペイン
      • Barcelona、スペイン、08036
        • 募集
        • Hospital Clinic de Barcelona
      • Barcelona、スペイン、08035
        • 募集
        • Hospital Universitari Vall D'Hebron
      • Barcelona、スペイン、08041
        • 募集
        • Hospital de La Santa Creu I Sant Pau
      • Madrid、スペイン、28041
        • 募集
        • Hospital Universitario 12 de Octubre
      • Madrid、スペイン、28034
        • 募集
        • Hospital Universitario Ramon Y Cajal
      • Madrid、スペイン、28009
        • 募集
        • Hospital General Universitario Gregorio Marañon
      • Málaga、スペイン、29010
        • 募集
        • HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.
      • Seville、スペイン、41009
        • 募集
        • Hospital Universitario Virgen Macarena
      • Valencia、スペイン、46010
        • 募集
        • Hospital Clinico Universitario de Valencia
  • ドイツ
      • Frankfurt、ドイツ、60488
        • 募集
        • Krankenhaus Nordwest GmbH
  • ノルウェー
      • Lørenskog、ノルウェー、1478
        • 完了
        • Haukeland universitetssjukehus
      • Lørenskog、ノルウェー、1478
        • 完了
        • Akershus universitetssykehus
      • Oslo、ノルウェー、0379
        • 募集
        • Oslo Universitetssykehus HF, Radiumhospitalet
  • ハンガリー
      • Kecskemét、ハンガリー、6000
        • 募集
        • Bacs-Kiskun Varmegyei Oktatokorhaz
  • フランス
      • Bordeaux、フランス、33000
        • 募集
        • Chu Bordeaux
      • Dijon、フランス、21079
        • 募集
        • Centre Georges Franăois Leclerc
      • Lille、フランス、59000
        • 募集
        • Hopital Claude Huriez - Chu Lille
      • Lyon、フランス、69008
        • 募集
        • Centre Léon Bérard
      • Marseille、フランス、13005
        • 募集
        • Hăpital de La Timone
      • Nantes、フランス、44093
        • 募集
        • Chu Nantes - Hătel Dieu
      • Toulouse、フランス、31100
        • 募集
        • Institut Claudius Regaud
      • Vandœuvre-lès-Nancy、フランス、54500
        • 募集
        • ICL - Alexis Vautrin
      • Villejuif、フランス、94805
        • 募集
        • Institut Gustave Roussy
  • ベルギー
      • Brussels、ベルギー
        • 募集
        • Cliniques Universitaires Saint-Luc
      • Edegem、ベルギー、2650
        • 募集
        • UZA
      • Ghent、ベルギー、9000
        • 募集
        • Universitair Ziekenhuis Gent
      • Jette、ベルギー
        • 募集
        • Universitair Ziekenhuis Brussel
      • Leuven、ベルギー、3000
        • 募集
        • UZ Leuven
  • 中国
      • Chengdu、中国、610098
        • 募集
        • West China Hospital, Sichuan University
      • Guangzhou、中国、510060
        • 募集
        • Sun Yat-sen University Cancer Center
  • 台湾
      • Kaohsiung City、台湾、833
        • 募集
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung、台湾、407219
        • 募集
        • Taichung Veterans General Hospital
      • Tainan、台湾、704
        • 募集
        • National Cheng Kung University Hospital
      • Taipei、台湾、11217
        • 募集
        • Taipei Veterans General Hospital
        • コンタクト：
          • See Central Contact
      • Taipei、台湾、100225
        • 募集
        • National Taiwan University Hospital
      • Taipei、台湾、11209
        • 募集
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei、台湾、104217
        • 募集
        • MacKay Memorial Hospital
      • Taoyuan、台湾、333
        • 募集
        • Chang Gung Memorial Hospital
  • 日本
      • Hidaka、日本、350-1298
        • 募集
        • Saitama Medical University International Medical Center
      • Kagoshima、日本、892-0833
        • 募集
        • HAKUAIKAI Social Medical Corporation Sagara Hospital
      • Kanagawa、日本、241-8515
        • 募集
        • Kanagawa Cancer Center
      • Kashiwa-shi、日本、277-8577
        • 募集
        • National Cancer Center Hospital East
        • コンタクト：
          • See Central Contact
      • Matsuyama、日本、791-0245
        • 募集
        • NHO Shikoku Cancer Center
        • コンタクト：
          • See Central Contact
      • Nagaizumi-cho、日本、411-8777
        • 募集
        • Shizuoka Cancer Center
        • コンタクト：
          • See Central Contact
      • Nagoya、日本、464-8681
        • 募集
        • Aichi Cancer Center Hospital
      • Osakasayama-shi、日本、589-8511
        • 募集
        • Kindai University Hospital
        • コンタクト：
          • See Central Contact
      • Saitama、日本、362-0806
        • 募集
        • Saitama Cancer Center
      • Tokyo、日本、104-0045
        • 募集
        • National Cancer Center Hospital
      • Tokyo、日本、135-8550
        • 募集
        • Cancer Institute Hospital of JFCR
      • Tokyo、日本、142-8666
        • 募集
        • SHOWA Medical University Hospital
      • Yokohama、日本、232-0024
        • 募集
        • Yokohama City University Medical Center
  • 韓国
      • Daegu、韓国、41404
        • 募集
        • Kyungpook National University Chilgok Hospital
      • Gyeonggi-do、韓国、410-769
        • 募集
        • National Cancer Center
      • Seongnam、韓国、13620
        • 募集
        • Seoul National University Bundang Hospital
      • Seongnam、韓国、13496
        • 募集
        • Cha Bundang Medical Center, Cha University
      • Seoul、韓国、05505
        • 募集
        • Asan Medical Center
      • Seoul、韓国、03080
        • 募集
        • Seoul National University Hospital
      • Seoul、韓国、03722
        • 募集
        • Severance Hospital, Yonsei University Health System
      • Seoul、韓国、06351
        • 募集
        • Samsung Medical Center

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for enrollment into the study:

  1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.

  2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).

  3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:

    Cutaneous (acral and non-acral) melanoma

    1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma

    2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors [ICIs] [ie, anti-CTLA4, anti- LAG-3] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF/MEK inhibitor therapy as well.

      Squamous cell carcinomas of the head and neck

    3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.

    4. Disease progression after having received treatment with ≥1 and <3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.

      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.

      Gastric or GEJ adenocarcinoma

    5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry [IHC] 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.

    6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.

      Ovarian Carcinoma

    7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

    8. Documented disease progression ≥4 weeks after the last dose of PBC and <6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.

      Cervical Cancer

    9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.

    10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and/or tissue factor directed ADC (tisotumab vedotin [TV]) per regional standard of care.

      Endometrial Cancer

    11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.

    12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.

      Bladder Cancer

    13. Pathologically or cytologically documented locally advanced/unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.

    14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.

      • Required treatments can be given in combination or sequentially
      • Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy
      • The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy
      • Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.

      Esophageal Carcinoma

    15. Pathologically or cytologically documented esophageal squamous cell carcinoma.

    16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.

      Pancreatic Carcinoma

    17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.

    18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced/metastatic setting.

      Prostate Cancer

    19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).

    20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.

    21. Surgically or medically castrated, with testosterone levels of <50 ng/dL.

    22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.

    23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.

    24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.

      Gastric Cancer 2L

    25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.

    26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.

    Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations [exon 19 deletion or L858R mutation], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1/2/3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.

    cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.

    Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+/ISH-, IHC1+, or IHC0 per ASCO/CAP guidelines), and HR positive (either ER and/or PgR positive [ER or PgR ≥1%] per ASCO/CAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.

    ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4/6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.

  4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.

  5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:

    1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).

      OR

    2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)

  6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.

Exclusion Criteria

Participants who meet any of the following criteria will be disqualified from entering the study:

  1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.

  2. Has nasopharyngeal cancer.

  3. Has mucosal or uveal melanoma.

  4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

  5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses

  6. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.

    Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.

  7. Had prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).

  8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:

    1. Adequately treated nonmelanoma skin cancer
    2. Adequately treated intraepithelial carcinoma of the cervix
    3. Any other curatively treated in situ disease

  9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol

  10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.

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：なし
  • 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）

武器と介入

参加者グループ / アーム
介入・治療
実験的：HER3-DXd Monotherapy

Participants with locally advanced unresectable or metastatic cancer (melanoma, head and neck, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer) will receive an intravenous infusion of HER3-DXd monotherapy 5.6 mg/kg every 3 weeks (Q3W).
薬：HER3-DXd

Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle

他の名前：
  • U3-1402
  • パトリツマブ デルクステカン

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
PSAの50%以上の減少を達成した参加者の割合（前立腺がんコホートのみ）
時間枠：ベースライン、注入前の各サイクル（各サイクルは 21 日）、および治療終了、最大約 27 か月
ベースライン、注入前の各サイクル（各サイクルは 21 日）、および治療終了、最大約 27 か月
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
時間枠：Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

二次結果の測定

結果測定
メジャーの説明
時間枠
HER3-DXd単独療法後に研究者が評価した無増悪生存期間（前立腺がんコホートを除くすべてのコホート）
時間枠：治験薬の投与開始日から、RECIST v1.1に従って治験責任医師が評価したX線写真による疾患の進行または何らかの原因による死亡の最初の客観的記録のいずれか早い日まで、最長約27か月
治験薬の投与開始日から、RECIST v1.1に従って治験責任医師が評価したX線写真による疾患の進行または何らかの原因による死亡の最初の客観的記録のいずれか早い日まで、最長約27か月
HER3-DXd 単独療法後の全生存期間 (全コホート)
時間枠：治験薬の投与開始日から、何らかの原因による死亡日のいずれか早い方まで、最長約27か月
治験薬の投与開始日から、何らかの原因による死亡日のいずれか早い方まで、最長約27か月
前立腺がんワーキンググループ 3 (PCWG3) の研究者による基準によって評価された X 線写真による無増悪生存期間 (rPFS)、または HER3-DXd 単剤療法後の何らかの原因による死亡 (前立腺がんコホートのみ)
時間枠：治験薬の投与開始日から、治験責任医師によるPCWG3基準に従って評価されたX線写真による疾患進行の最初の客観的記録の日、または何らかの原因による死亡のいずれか早い日まで、最長約27か月
治験薬の投与開始日から、治験責任医師によるPCWG3基準に従って評価されたX線写真による疾患進行の最初の客観的記録の日、または何らかの原因による死亡のいずれか早い日まで、最長約27か月
PSAの30%以上の減少を達成した参加者の割合（前立腺がんコホートのみ）
時間枠：ベースライン、注入前の各サイクル（各サイクルは 21 日）、および治療終了、最大約 27 か月
ベースライン、注入前の各サイクル（各サイクルは 21 日）、および治療終了、最大約 27 か月
最初の後続抗がん療法 (TFST) までの時間 (前立腺がんコホートのみ)
時間枠：治験薬の投与開始日から、その後の最初の抗がん剤治療の開始または死亡のいずれか早い方まで、最長約27か月
治験薬の投与開始日から、その後の最初の抗がん剤治療の開始または死亡のいずれか早い方まで、最長約27か月
最初の症候性骨格関連イ​​ベント (SSRE) までの時間 (前立腺がんコホートのみ)
時間枠：治験薬の投与開始日から以下のいずれかの最初の発生まで：EBRTの使用、新たな症候性の病的骨折、脊髄圧迫、腫瘍関連の整形外科的介入、最長約27か月
治験薬の投与開始日から以下のいずれかの最初の発生まで：EBRTの使用、新たな症候性の病的骨折、脊髄圧迫、腫瘍関連の整形外科的介入、最長約27か月
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)
時間枠：Baseline up to 27 months

Adverse events (AEs) will be coded using MedDRA and AEs and will be graded by using NCI-CTCAE v5.0.
Baseline up to 27 months
Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
時間枠：From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 27 months

Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.
From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 27 months
Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
時間枠：Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

Clinical benefit rate (CBR) is the proportion of participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days.
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months
Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
時間枠：Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1.
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months
Time to Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
時間枠：From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 27 months

Time to response (TTR) will be calculated for confirmed responders only.
From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 27 months
Pharmacokinetic Parameter Maximum Serum Concentration for HER3-DXd (All Cohorts)
時間枠：Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

Maximum serum concentration (Cmax) will be assessed using non-compartmental methods.
Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)
Pharmacokinetic Parameter Time to Maximum Serum Concentration for HER3-DXd (All Cohorts)
時間枠：Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

Time to maximum serum concentration (Tmax) will be assessed using non-compartmental methods.
Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)
Pharmacokinetic Parameter Trough Serum Concentration (Ctrough) for HER3-DXd (All Cohorts)
時間枠：Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

Trough serum concentration (Ctrough) will be assessed using non-compartmental methods.
Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)
Pharmacokinetic Parameter Area Under the Concentration Curve for HER3-DXd (All Cohorts)
時間枠：Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

Area under the concentration-time curve up to the last quantifiable time (AUClast) and Area under the concentration-time curve during dosing interval (AUCtau) will be assessed using non-compartmental methods.
Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)
Correlation Between HER3 Protein Expression and Efficacy
時間枠：From the start date of study drug up to approximately 27 months

HER3 protein expression in tumor tissue as determined by IHC and correlation with ORR, DoR, and PFS.
From the start date of study drug up to approximately 27 months

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。

スポンサー

Daiichi Sankyo

協力者

Merck Sharp & Dohme LLC

捜査官

  • スタディディレクター：Global Clinical Leader、Daiichi Sankyo

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2024年2月26日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2028年10月10日

試験登録日

最初に提出

2023年12月7日

QC基準を満たした最初の提出物

2023年12月7日

最初の投稿 (実際)

2023年12月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月26日

QC基準を満たした最後の更新が送信されました

2026年10月23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

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • U31402-277
  • 2023-507641-29-00 (その他の識別子：EU CTIS)
  • jRCT2031230575 (その他の識別子：jRCT)
  • 2023 (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?

はい

IPD プランの説明

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD 共有時間枠

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD 共有アクセス基準

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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

はい

米国FDA規制機器製品の研究

いいえ

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