이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

국소 진행성 또는 전이성 고형 종양이 있는 피험자를 대상으로 한 HER3-DXd에 대한 연구

2026년 10월 23일 업데이트: Daiichi Sankyo

HERTHENA-PanTumor01(U31402-277): 국소 진행성 또는 전이성 고형 종양이 있는 피험자를 대상으로 한 Patritumab Deruxtecan(HER3-DXd; U3-1402)의 2상, 다기관, 다코호트, 공개 라벨, 개념 증명 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

740

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Daiichi Sankyo Contact for Clinical Trial Information
  • 전화번호: 9089926400
  • 이메일: CTRinfo@dsi.com

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

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  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
의약품: HER3-DXd

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

다른 이름들:
  • U3-1402
  • 파트리투맙 데룩스테칸

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
PSA가 50% 이상 감소한 참가자 비율(전립선암 코호트에만 해당)
기간: 기준선, 주입 전 각 주기(각 주기는 21일) 및 치료 종료, 최대 약 27개월
기준선, 주입 전 각 주기(각 주기는 21일) 및 치료 종료, 최대 약 27개월
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
HER3-DXd 단독요법 후 조사자가 평가한 무진행 생존(전립선암 코호트를 제외한 모든 코호트)
기간: 연구 약물의 시작일부터 RECIST v1.1에 따라 조사자가 평가한 방사선학적 질병 진행 또는 어떤 원인으로 인한 사망(먼저 발생하는 날짜 기준)에 대한 첫 번째 객관적인 기록의 더 빠른 날짜까지, 최대 약 27개월
연구 약물의 시작일부터 RECIST v1.1에 따라 조사자가 평가한 방사선학적 질병 진행 또는 어떤 원인으로 인한 사망(먼저 발생하는 날짜 기준)에 대한 첫 번째 객관적인 기록의 더 빠른 날짜까지, 최대 약 27개월
HER3-DXd 단독요법 후 전체 생존율(모든 코호트)
기간: 연구 약물 시작일부터 어떤 원인으로든 사망한 날짜 중 먼저 발생하는 날짜까지 최대 약 27개월
연구 약물 시작일부터 어떤 원인으로든 사망한 날짜 중 먼저 발생하는 날짜까지 최대 약 27개월
전립선암 실무 그룹 3(PCWG3) 기준에 의해 조사자가 평가한 방사선학적 무진행 생존율(rPFS) 또는 HER3-DXd 단독요법 후 모든 원인으로 인한 사망(전립선암 코호트에만 해당)
기간: 연구 약물 시작일부터 시험자가 PCWG3 기준에 따라 평가한 방사선학적 질병 진행에 대한 첫 번째 객관적 문서화의 더 빠른 날짜까지 또는 어떤 원인으로 인한 사망 중 먼저 발생하는 날짜까지, 최대 약 27개월
연구 약물 시작일부터 시험자가 PCWG3 기준에 따라 평가한 방사선학적 질병 진행에 대한 첫 번째 객관적 문서화의 더 빠른 날짜까지 또는 어떤 원인으로 인한 사망 중 먼저 발생하는 날짜까지, 최대 약 27개월
PSA가 30% 이상 감소한 참가자 비율(전립선암 코호트에만 해당)
기간: 기준선, 주입 전 각 주기(각 주기는 21일) 및 치료 종료, 최대 약 27개월
기준선, 주입 전 각 주기(각 주기는 21일) 및 치료 종료, 최대 약 27개월
1차 후속 항암 치료(TFST)까지의 시간(전립선암 코호트에만 해당)
기간: 연구 약물 시작일부터 첫 번째 후속 항암 요법 시작 또는 사망 중 먼저 발생하는 날짜까지 최대 약 27개월
연구 약물 시작일부터 첫 번째 후속 항암 요법 시작 또는 사망 중 먼저 발생하는 날짜까지 최대 약 27개월
첫 번째 증상이 있는 골격 관련 사건(SSRE)까지의 시간(전립선암 코호트에만 해당)
기간: 연구 약물 시작일부터 다음 중 첫 번째 발생까지: EBRT 사용, 새로운 증상이 있는 병리학적 골절, 척수 압박, 종양 관련 정형외과 수술 중재, 최대 약 27개월
연구 약물 시작일부터 다음 중 첫 번째 발생까지: EBRT 사용, 새로운 증상이 있는 병리학적 골절, 척수 압박, 종양 관련 정형외과 수술 중재, 최대 약 27개월
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Daiichi Sankyo

협력자

Merck Sharp & Dohme LLC

수사관

  • 연구 책임자: Global Clinical Leader, Daiichi Sankyo

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 2월 26일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2028년 10월 10일

연구 등록 날짜

최초 제출

2023년 12월 7일

QC 기준을 충족하는 최초 제출

2023년 12월 7일

처음 게시됨 (실제)

2023년 12월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 23일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • U31402-277
  • 2023-507641-29-00 (기타 식별자: EU CTIS)
  • jRCT2031230575 (기타 식별자: jRCT)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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