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Un estudio de HER3-DXd en sujetos con tumores sólidos localmente avanzados o metastásicos

23 de octubre de 2026 actualizado por: Daiichi Sankyo

HERTHENA-PanTumor01 (U31402-277): estudio de fase 2, multicéntrico, multicohorte, abierto, de prueba de concepto de patritumab deruxtecan (HER3-DXd; U3-1402) en sujetos con tumores sólidos localmente avanzados o metastásicos

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

740

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Daiichi Sankyo Contact for Clinical Trial Information
  • Número de teléfono: 9089926400
  • Correo electrónico: CTRinfo@dsi.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).
Droga: HER3-DXd

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

Otros nombres:
  • U3-1402
  • Patritumab Deruxtecán

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proporción de participantes que lograron una disminución ≥50 % en el PSA (solo cohorte de cáncer de próstata)
Periodo de tiempo: Valor inicial, cada ciclo antes de la infusión (cada ciclo dura 21 días) y final del tratamiento, hasta aproximadamente 27 meses
Valor inicial, cada ciclo antes de la infusión (cada ciclo dura 21 días) y final del tratamiento, hasta aproximadamente 27 meses
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Supervivencia libre de progresión según la evaluación del investigador después de la monoterapia con HER3-DXd (todas las cohortes excepto la cohorte de cáncer de próstata)
Periodo de tiempo: Desde la fecha de inicio del fármaco del estudio hasta la fecha anterior de la primera documentación objetiva de la progresión de la enfermedad radiográfica según la evaluación del investigador según RECIST v1.1 o muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Desde la fecha de inicio del fármaco del estudio hasta la fecha anterior de la primera documentación objetiva de la progresión de la enfermedad radiográfica según la evaluación del investigador según RECIST v1.1 o muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Supervivencia general después de la monoterapia con HER3-DXd (todas las cohortes)
Periodo de tiempo: Desde la fecha de inicio del fármaco del estudio hasta la fecha de muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Desde la fecha de inicio del fármaco del estudio hasta la fecha de muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Supervivencia libre de progresión radiográfica (rPFS) según la evaluación del investigador según los criterios del Grupo de trabajo 3 sobre cáncer de próstata (PCWG3) o muerte por cualquier causa después de la monoterapia con HER3-DXd (solo cohorte de cáncer de próstata)
Periodo de tiempo: Desde la fecha de inicio del fármaco del estudio hasta la fecha anterior de la primera documentación objetiva de la progresión de la enfermedad radiográfica según lo evaluado según los criterios del PCWG3 por el investigador o la muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Desde la fecha de inicio del fármaco del estudio hasta la fecha anterior de la primera documentación objetiva de la progresión de la enfermedad radiográfica según lo evaluado según los criterios del PCWG3 por el investigador o la muerte por cualquier causa, lo que ocurra primero, hasta aproximadamente 27 meses
Proporción de participantes que lograron una disminución ≥30 % en el PSA (solo cohorte de cáncer de próstata)
Periodo de tiempo: Valor inicial, cada ciclo antes de la infusión (cada ciclo dura 21 días) y final del tratamiento, hasta aproximadamente 27 meses
Valor inicial, cada ciclo antes de la infusión (cada ciclo dura 21 días) y final del tratamiento, hasta aproximadamente 27 meses
Tiempo hasta la primera terapia anticancerígena posterior (TFST) (solo cohorte de cáncer de próstata)
Periodo de tiempo: Desde la fecha de inicio del fármaco del estudio hasta el inicio de la primera terapia anticancerígena posterior o la muerte, lo que ocurra primero, hasta aproximadamente 27 meses.
Desde la fecha de inicio del fármaco del estudio hasta el inicio de la primera terapia anticancerígena posterior o la muerte, lo que ocurra primero, hasta aproximadamente 27 meses.
Tiempo hasta el primer evento sintomático relacionado con el esqueleto (SSRE) (solo cohorte de cáncer de próstata)
Periodo de tiempo: Desde la fecha de inicio del fármaco del estudio hasta la primera aparición de cualquiera de los siguientes: uso de EBRT, nueva fractura ósea patológica sintomática, compresión de la médula espinal, una intervención quirúrgica ortopédica relacionada con un tumor, hasta aproximadamente 27 meses
Desde la fecha de inicio del fármaco del estudio hasta la primera aparición de cualquiera de los siguientes: uso de EBRT, nueva fractura ósea patológica sintomática, compresión de la médula espinal, una intervención quirúrgica ortopédica relacionada con un tumor, hasta aproximadamente 27 meses
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Daiichi Sankyo

Colaboradores

Merck Sharp & Dohme LLC

Investigadores

  • Director de estudio: Global Clinical Leader, Daiichi Sankyo

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de febrero de 2024

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

10 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de diciembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

7 de diciembre de 2023

Publicado por primera vez (Actual)

15 de diciembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de octubre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • U31402-277
  • 2023-507641-29-00 (Otro identificador: EU CTIS)
  • jRCT2031230575 (Otro identificador: jRCT)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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/

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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