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Eine Studie zu HER3-DXd bei Patienten mit lokal fortgeschrittenen oder metastasierten soliden Tumoren

23. Oktober 2026 aktualisiert von: Daiichi Sankyo

HERTHENA-PanTumor01 (U31402-277): Eine multizentrische, multikohorte, offene Proof-of-Concept-Studie der Phase 2 zu Patritumab Deruxtecan (HER3-DXd; U3-1402) bei Patienten mit lokal fortgeschrittenen oder metastasierten soliden Tumoren

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

740

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Daiichi Sankyo Contact for Clinical Trial Information
  • Telefonnummer: 9089926400
  • E-Mail: CTRinfo@dsi.com

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
Arzneimittel: HER3-DXd

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

Andere Namen:
  • U3-1402
  • Patritumab Deruxtecan

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anteil der Teilnehmer, die eine Senkung des PSA um ≥ 50 % erreichen (nur Prostatakrebs-Kohorte)
Zeitfenster: Ausgangswert, jeder Zyklus vor der Infusion (jeder Zyklus dauert 21 Tage) und Ende der Behandlung, bis zu etwa 27 Monaten
Ausgangswert, jeder Zyklus vor der Infusion (jeder Zyklus dauert 21 Tage) und Ende der Behandlung, bis zu etwa 27 Monaten
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Vom Prüfarzt beurteiltes progressionsfreies Überleben nach HER3-DXd-Monotherapie (alle Kohorten außer Prostatakrebs-Kohorte)
Zeitfenster: Vom Startdatum des Studienmedikaments bis zum früheren Datum der ersten objektiven Dokumentation des radiologischen Krankheitsverlaufs, wie vom Prüfer gemäß RECIST v1.1 beurteilt, oder bis zum Tod aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Vom Startdatum des Studienmedikaments bis zum früheren Datum der ersten objektiven Dokumentation des radiologischen Krankheitsverlaufs, wie vom Prüfer gemäß RECIST v1.1 beurteilt, oder bis zum Tod aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Gesamtüberleben nach HER3-DXd-Monotherapie (alle Kohorten)
Zeitfenster: Vom Startdatum des Studienmedikaments bis zum Datum des Todes aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Vom Startdatum des Studienmedikaments bis zum Datum des Todes aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Radiologisches progressionsfreies Überleben (rPFS) gemäß den Kriterien der Prostatakrebs-Arbeitsgruppe 3 (PCWG3) durch den Prüfer oder Tod aus irgendeinem Grund nach HER3-DXd-Monotherapie (nur Prostatakrebs-Kohorte)
Zeitfenster: Vom Startdatum des Studienmedikaments bis zum früheren Datum der ersten objektiven Dokumentation des radiologischen Krankheitsverlaufs gemäß PCWG3-Kriterien durch den Prüfer oder Tod aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Vom Startdatum des Studienmedikaments bis zum früheren Datum der ersten objektiven Dokumentation des radiologischen Krankheitsverlaufs gemäß PCWG3-Kriterien durch den Prüfer oder Tod aus irgendeinem Grund, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Anteil der Teilnehmer, die eine PSA-Senkung von ≥ 30 % erreichen (nur Prostatakrebs-Kohorte)
Zeitfenster: Ausgangswert, jeder Zyklus vor der Infusion (jeder Zyklus dauert 21 Tage) und Ende der Behandlung, bis zu etwa 27 Monaten
Ausgangswert, jeder Zyklus vor der Infusion (jeder Zyklus dauert 21 Tage) und Ende der Behandlung, bis zu etwa 27 Monaten
Zeit bis zur ersten anschließenden Krebstherapie (TFST) (nur Prostatakrebs-Kohorte)
Zeitfenster: Vom Startdatum des Studienmedikaments bis zum Beginn der ersten nachfolgenden Krebstherapie oder zum Tod, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Vom Startdatum des Studienmedikaments bis zum Beginn der ersten nachfolgenden Krebstherapie oder zum Tod, je nachdem, was zuerst eintritt, bis zu etwa 27 Monaten
Zeit bis zum ersten symptomatischen skelettbezogenen Ereignis (SSRE) (nur Prostatakrebs-Kohorte)
Zeitfenster: Vom Startdatum des Studienmedikaments bis zum ersten Auftreten eines der folgenden Ereignisse: Einsatz von EBRT, neuer symptomatischer pathologischer Knochenbruch, Rückenmarkskompression, ein tumorbedingter orthopädischer chirurgischer Eingriff, bis zu etwa 27 Monate
Vom Startdatum des Studienmedikaments bis zum ersten Auftreten eines der folgenden Ereignisse: Einsatz von EBRT, neuer symptomatischer pathologischer Knochenbruch, Rückenmarkskompression, ein tumorbedingter orthopädischer chirurgischer Eingriff, bis zu etwa 27 Monate
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Daiichi Sankyo

Mitarbeiter

Merck Sharp & Dohme LLC

Ermittler

  • Studienleiter: Global Clinical Leader, Daiichi Sankyo

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Februar 2024

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

10. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

7. Dezember 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Dezember 2023

Zuerst gepostet (Tatsächlich)

15. Dezember 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Oktober 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • U31402-277
  • 2023-507641-29-00 (Andere Kennung: EU CTIS)
  • jRCT2031230575 (Andere Kennung: jRCT)
  • 2023 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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