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Une étude de HER3-DXd chez des sujets atteints de tumeurs solides localement avancées ou métastatiques

23 octobre 2026 mis à jour par: Daiichi Sankyo

HERTHENA-PanTumor01 (U31402-277) : étude de phase 2, multicentrique, multicohorte, ouverte, de preuve de concept du Patritumab Deruxtecan (HER3-DXd ; U3-1402) chez des sujets atteints de tumeurs solides localement avancées ou métastatiques

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

740

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Daiichi Sankyo Contact for Clinical Trial Information
  • Numéro de téléphone: 9089926400
  • E-mail: CTRinfo@dsi.com

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Médicament: HER3-DXd

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

Autres noms:
  • U3-1402
  • Patritumab Deruxtécan

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion de participants atteignant une diminution ≥ 50 % du PSA (cohorte du cancer de la prostate uniquement)
Délai: Au départ, chaque cycle avant la perfusion (chaque cycle dure 21 jours) et à la fin du traitement, jusqu'à environ 27 mois
Au départ, chaque cycle avant la perfusion (chaque cycle dure 21 jours) et à la fin du traitement, jusqu'à environ 27 mois
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Survie sans progression telle qu'évaluée par l'investigateur après la monothérapie HER3-DXd (toutes les cohortes sauf la cohorte du cancer de la prostate)
Délai: De la date de début du médicament à l'étude jusqu'à la date la plus rapprochée de la première documentation objective de la progression radiographique de la maladie, telle qu'évaluée par l'investigateur selon RECIST v1.1, ou du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
De la date de début du médicament à l'étude jusqu'à la date la plus rapprochée de la première documentation objective de la progression radiographique de la maladie, telle qu'évaluée par l'investigateur selon RECIST v1.1, ou du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
Survie globale après la monothérapie HER3-DXd (toutes les cohortes)
Délai: De la date de début du traitement à l'étude jusqu'à la date du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
De la date de début du traitement à l'étude jusqu'à la date du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
Survie sans progression radiographique (rPFS) telle qu'évaluée par les critères du groupe de travail 3 sur le cancer de la prostate (PCWG3) par l'investigateur ou décès quelle qu'en soit la cause après la monothérapie HER3-DXd (cohorte du cancer de la prostate uniquement)
Délai: De la date de début du médicament à l'étude jusqu'à la date la plus rapprochée de la première documentation objective de la progression radiographique de la maladie, telle qu'évaluée selon les critères du PCWG3 par l'investigateur, ou du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
De la date de début du médicament à l'étude jusqu'à la date la plus rapprochée de la première documentation objective de la progression radiographique de la maladie, telle qu'évaluée selon les critères du PCWG3 par l'investigateur, ou du décès, quelle qu'en soit la cause, selon la première éventualité, jusqu'à environ 27 mois.
Proportion de participants atteignant une diminution ≥ 30 % du PSA (cohorte du cancer de la prostate uniquement)
Délai: Au départ, chaque cycle avant la perfusion (chaque cycle dure 21 jours) et à la fin du traitement, jusqu'à environ 27 mois
Au départ, chaque cycle avant la perfusion (chaque cycle dure 21 jours) et à la fin du traitement, jusqu'à environ 27 mois
Délai avant la première thérapie anticancéreuse ultérieure (TFST) (cohorte du cancer de la prostate uniquement)
Délai: De la date de début du médicament à l'étude jusqu'au début du premier traitement anticancéreux ultérieur ou au décès, selon la première éventualité, jusqu'à environ 27 mois.
De la date de début du médicament à l'étude jusqu'au début du premier traitement anticancéreux ultérieur ou au décès, selon la première éventualité, jusqu'à environ 27 mois.
Délai avant le premier événement symptomatique lié au squelette (SSRE) (cohorte du cancer de la prostate uniquement)
Délai: De la date de début du médicament à l'étude jusqu'à la première apparition de l'un des éléments suivants : utilisation de l'EBRT, nouvelle fracture osseuse pathologique symptomatique, compression de la moelle épinière, intervention chirurgicale orthopédique liée à une tumeur, jusqu'à environ 27 mois.
De la date de début du médicament à l'étude jusqu'à la première apparition de l'un des éléments suivants : utilisation de l'EBRT, nouvelle fracture osseuse pathologique symptomatique, compression de la moelle épinière, intervention chirurgicale orthopédique liée à une tumeur, jusqu'à environ 27 mois.
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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Daiichi Sankyo

Collaborateurs

Merck Sharp & Dohme LLC

Les enquêteurs

  • Directeur d'études: Global Clinical Leader, Daiichi Sankyo

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 février 2024

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

10 octobre 2028

Dates d'inscription aux études

Première soumission

7 décembre 2023

Première soumission répondant aux critères de contrôle qualité

7 décembre 2023

Première publication (Réel)

15 décembre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 octobre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • U31402-277
  • 2023-507641-29-00 (Autre identifiant: EU CTIS)
  • jRCT2031230575 (Autre identifiant: jRCT)
  • 2023 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime 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/

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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