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Beamion BCGC-1: En undersøgelse for at finde en passende dosis af Zongertinib i kombination med Trastuzumab Deruxtecan eller med Trastuzumab Emtansine og for at teste, om det hjælper mennesker med forskellige typer HER2+-kræft, der har spredt sig

3. november 2026 opdateret af: Boehringer Ingelheim

Beamion BCGC-1: En fase Ib-dosiseskalering og fase II-dosisoptimering, randomiseret, åbent, multicenterforsøg med oral Zongertinib (BI 1810631) i kombination med intravenøs trastuzumab deruxtecan (T-DXd) eller i kombination med intravenøs emtanstune T-DM1) til behandling af patienter med avanceret HER2+ metastatisk brystcancer (mBC) og metastatisk gastrisk, gastroøsofageal forbindelse eller esophageal adenokarcinom (mGEAC)

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken alone or together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab with or without capecitabine, with zanidatamab with or without docetaxel, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.

In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.

During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken alone or together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

910

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Belgien
      • Brussels, Belgien, 1200
        • Rekruttering
        • Cliniques Universitaires Saint-Luc
        • Kontakt:
      • Edegem, Belgien, 2650
        • Rekruttering
        • Universitair Ziekenhuis Antwerpen
        • Kontakt:
      • Leuven, Belgien, 3000
      • Libramont-Chevigny, Belgien, 6800
        • Rekruttering
        • Hôpital Vivalia De Libramont
        • Kontakt:
      • Liège, Belgien, 4000
        • Afsluttet
        • Centre Hospitalier Universitaire de Liège
      • Namur, Belgien, 5000
  • Det Forenede Kongerige
      • Cardiff, Det Forenede Kongerige, CF14 2TL
      • Leeds, Det Forenede Kongerige, LS9 7TF
      • London, Det Forenede Kongerige, NW3 2QG
      • London, Det Forenede Kongerige, EC1A 7BE
      • London, Det Forenede Kongerige, NW1 2BU
      • London, Det Forenede Kongerige, SW3 6JJ
      • Manchester, Det Forenede Kongerige, M20 4BX
      • Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
      • Nottingham, Det Forenede Kongerige, NG5 1PB
      • Sutton, Det Forenede Kongerige, SM2 5PT
  • Forenede Stater
    • California
      • Cerritos, California, Forenede Stater, 90703
        • Rekruttering
        • The Oncology Institute of Hope and Innovation
        • Kontakt:
      • Los Angeles, California, Forenede Stater, 90095
      • Los Angeles, California, Forenede Stater, 90067
      • Los Angeles, California, Forenede Stater, 90064
      • Orange, California, Forenede Stater, 92868
      • San Diego, California, Forenede Stater, 92123
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
    • Florida
      • Lakeland, Florida, Forenede Stater, 33812
      • Tampa, Florida, Forenede Stater, 33612
        • Rekruttering
        • H. Lee Moffitt Cancer Center and Research Institute
        • Kontakt:
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
    • New York
      • New York, New York, Forenede Stater, 10065
      • Shirley, New York, Forenede Stater, 11967
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Rekruttering
        • Penn State Milton S. Hershey Medical Center
        • Kontakt:
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
      • Nashville, Tennessee, Forenede Stater, 37203
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • The University of Texas MD Anderson Cancer Center
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77030
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
      • Fairfax, Virginia, Forenede Stater, 22031
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
  • Frankrig
      • Bordeaux, Frankrig, 33000
      • Caen, Frankrig, 14076
        • Rekruttering
        • CTR François Baclesse
        • Kontakt:
      • Lyon, Frankrig, 69008
      • Marseille, Frankrig, 13273
      • Paris, Frankrig, 75020
      • Rennes, Frankrig, 35042
        • Ikke rekrutterer endnu
        • CTR Eugène Marquis
        • Kontakt:
      • Saint-Herblain, Frankrig, 44800
        • Rekruttering
        • Institut de Cancérologie de l'Ouest
        • Kontakt:
      • Strasbourg, Frankrig, 67200
        • Rekruttering
        • Institut de Cancérologie de Strasbourg
        • Kontakt:
      • Toulouse, Frankrig, 31059
        • Rekruttering
        • INS Claudius Regaud IUCT-Oncopole
        • Kontakt:
      • Villejuif, Frankrig, 94805
        • Rekruttering
        • Institut Gustave Roussy
        • Kontakt:
  • Italien
      • Ancona, Italien, 60126
        • Rekruttering
        • Azienda Ospedaliero Universitaria delle Marche
        • Kontakt:
      • Candiolo (TO), Italien, 10060
      • Meldola (FC), Italien, 47014
        • Rekruttering
        • Istituto Scientifico Romagnolo
        • Kontakt:
      • Milan, Italien, 20141
        • Rekruttering
        • Istituto Europeo di Oncologia
        • Kontakt:
      • Milan, Italien, 20132
        • Rekruttering
        • Ospedale San Raffaele S.r.l.
        • Kontakt:
      • Misterbianco (CT), Italien, 95045
        • Rekruttering
        • Humanitas Istituto Clinico Catanese S.p.A.
        • Kontakt:
      • Naples, Italien, 80131
        • Rekruttering
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
        • Kontakt:
      • Rozzano, Italien, 20089
        • Rekruttering
        • Istituto Clinico Humanitas
        • Kontakt:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Rekruttering
        • Aichi Cancer Center Hospital
        • Kontakt:
      • Isehara, Japan, 259-1193
        • Rekruttering
        • Tokai University Hospital
        • Kontakt:
      • Kagoshima, Japan, 892-0833
        • Rekruttering
        • Hakuaikai Sagara Hospital
        • Kontakt:
      • Kanagawa, Yokohama, Japan, 241-8515
        • Rekruttering
        • Kanagawa Cancer Center
        • Kontakt:
      • Kashiwa-shi, Japan, 277-8577
        • Rekruttering
        • National Cancer Center Hospital East
        • Kontakt:
      • Kyoto, Japan, 606-8507
        • Rekruttering
        • Kyoto University Hospital
        • Kontakt:
      • Osaka, Japan, 541-8567
        • Rekruttering
        • Osaka International Cancer Institute
        • Kontakt:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Rekruttering
        • Japanese Foundation for Cancer Research
        • Kontakt:
  • Kina
      • Changchun, Kina, 130021
        • Rekruttering
        • The First Hospital of Jilin University
        • Kontakt:
      • Changchun, Kina, 130012
        • Rekruttering
        • Jilin Province Cancer Hospital
        • Kontakt:
      • Hangzhou, Kina, 310000
        • Rekruttering
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Kontakt:
      • Harbin, Kina, 150081
        • Rekruttering
        • Harbin Medical University Cancer Hospital
        • Kontakt:
      • Nanjing, Kina, 210029
        • Rekruttering
        • Jiangsu Province Hospital
        • Kontakt:
      • Shanghai, Kina, 200032
        • Rekruttering
        • Fudan University Shanghai Cancer Center
        • Kontakt:
      • Tianjin, Kina, 300060
        • Rekruttering
        • Tianjin Cancer Hospital
        • Kontakt:
      • Zhengzhou, Kina, 450003
        • Rekruttering
        • Henan Cancer Hospital
        • Kontakt:
  • Spanien
      • A Coruña, Spanien, 15006
        • Rekruttering
        • Complejo Hospitalario Universitario A Coruña
        • Kontakt:
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
      • Barcelona, Spanien, 08003
      • Barcelona, Spanien, 08036
        • Rekruttering
        • Hospital Clínic de Barcelona
        • Kontakt:
      • L'Hospitalet de Llobregat, Spanien, 8906
        • Rekruttering
        • Hospital Duran i Reynals
        • Kontakt:
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
        • Kontakt:
      • Madrid, Spanien, 28046
        • Rekruttering
        • Hospital Universitario La Paz
        • Kontakt:
      • Madrid, Spanien, 28007
        • Rekruttering
        • Hospital General Universitario Gregorio Marañón
        • Kontakt:
      • Madrid, Spanien, 28040
        • Rekruttering
        • Fundación Jiménez Díaz
        • Kontakt:
      • Madrid, Spanien, 28050
      • Madrid, Spanien, 28040
        • Rekruttering
        • Hospital Clínico San Carlos
        • Kontakt:
      • Madrid, Spanien, 28022
        • Rekruttering
        • Clínica Universidad de Navarra - Madrid
        • Kontakt:
      • Seville, Spanien, 41009
        • Rekruttering
        • Hospital Universitario Virgen De La Macarena
        • Kontakt:
      • Valencia, Spanien, 46009
        • Rekruttering
        • Instituto Valenciano de Oncología
        • Kontakt:
  • Sydkorea
      • Seongnam-si, Sydkorea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:
      • Seongnam-si, Sydkorea, 13496
        • Rekruttering
        • CHA Bundang Medical Center
        • Kontakt:
      • Seoul, Sydkorea, 05505
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Severance Hospital, Yonsei University Health System
        • Kontakt:
      • Seoul, Sydkorea, 2841
        • Rekruttering
        • Korea University Anam Hospital
        • Kontakt:
      • Seoul, Sydkorea, 6591
        • Rekruttering
        • Severance Hospital, Yonsei University Health System
        • Kontakt:
      • Seoul, Sydkorea, 6273
        • Rekruttering
        • The Catholic University of Korea, Seoul St.Mary's Hospital
        • Kontakt:
  • Tyskland
      • Dresden, Tyskland, 01307
        • Rekruttering
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Kontakt:
      • Erlangen, Tyskland, 91054
      • Essen, Tyskland, 45136
        • Ikke rekrutterer endnu
        • Evang. Kliniken Essen-Mitte gGmbh
        • Kontakt:
      • Hamburg, Tyskland, 22763
      • Mannheim, Tyskland, 68167
      • Ulm, Tyskland, 89075

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)
  • Cohorts A to K and Cohort O and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).
  • Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification
  • For (Phase II): Patient must provide tumor tissue
  • History of prior treatment lines in palliative setting: For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K, O and P documented investigator assessed progression
  • Presence of at least one measurable lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Adequate organ function based on laboratory values Further inclusion criteria apply.

Exclusion criteria:

  • Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) >470 msec.
  • Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.
  • Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab emtansine

Trastuzumab emtansine

Andre navne:
  • T-DM1; Kadcyla®
Eksperimentel: Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab deruxtecan

Trastuzumab deruxtecan

Andre navne:
  • T-DXd; Enhertu®
Eksperimentel: Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab deruxtecan

Trastuzumab deruxtecan

Andre navne:
  • T-DXd; Enhertu®
Eksperimentel: Phase II - Cohort D: zongertinib + Trastuzumab emtansine

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab emtansine

Trastuzumab emtansine

Andre navne:
  • T-DM1; Kadcyla®
Eksperimentel: Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab deruxtecan

Trastuzumab deruxtecan

Andre navne:
  • T-DXd; Enhertu®
Eksperimentel: Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab deruxtecan

Trastuzumab deruxtecan

Andre navne:
  • T-DXd; Enhertu®
Eksperimentel: Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Medicin: Capecitabine

Capecitabine
Eksperimentel: Phase Ib - Cohort K: zongertinib + trastuzumab

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Eksperimentel: Phase II - Cohort H: zongertinib + trastuzumab + capecitabine

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Medicin: Capecitabine

Capecitabine
Eksperimentel: Phase II - Cohort I: zongertinib

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase II - Cohort J: zongertinib + trastuzumab

Dose optimization (Phase II).
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Eksperimentel: Phase II - Cohort I-ext: zongertinib

Extension Phase II
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase II - Cohort J-ext: zongertinib + trastuzumab

Extension Phase II
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Eksperimentel: Phase Ib - Cohort M: zongertinib + mFOLFOX6

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: mFOLFOX6

mFOLFOX6 (oxaliplatin, calcium folinate, 5-fluorouracil)
Eksperimentel: Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6

Dose escalation (Phase Ib)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Medicin: mFOLFOX6

mFOLFOX6 (oxaliplatin, calcium folinate, 5-fluorouracil)
Eksperimentel: Phase Ib - Cohort O: zongertinib + zanidatamab

Dose escalation (Phase Ib) - is not conducted in China or South Korea
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: zanidatamab

zanidatamab
Eksperimentel: Phase Ib - Cohort P: zongertinib + zanidatamab + docetaxel

Dose escalation (Phase 1b) - is not conducted in China or South Korea
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: zanidatamab

zanidatamab

Medicin: Docetaxel

Docetaxel
Eksperimentel: Phase II - Cohort L: zongertinib + trastuzumab

Dose justification (Phase II)
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®
Eksperimentel: Phase II - Cohort L-ext: zongertinib + trastuzumab

Extension Phase II
Medicin: Zongertinib

Zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Medicin: Trastuzumab

Trastuzumab

Andre navne:
  • Herceptin®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Tidsramme: up to 21 days

The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, O and P. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
up to 21 days
Dose optimization and justification (Phase II): Objective response (OR)
Tidsramme: up to 50 months

Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.
up to 50 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dosiseskalering (Fase Ib): Objektiv respons (ELLER)
Tidsramme: op til 50 måneder
op til 50 måneder
Dosiseskalering (fase Ib): Forekomst af dosisbegrænsende toksiciteter (DLT'er) under hele behandlingsperioden
Tidsramme: op til 50 måneder
op til 50 måneder
Dosisoptimering og -begrundelse (fase II): Forekomst af behandlingsrelaterede bivirkninger, der fører til dosisreduktion af zongertinib (BI 1810631) i løbet af behandlingsperioden
Tidsramme: op til 50 måneder
op til 50 måneder
Dosisoptimering og begrundelse (fase II): Maksimalt målte koncentration (ved stationær tilstand) (Cmax,(ss))
Tidsramme: op til 50 måneder
op til 50 måneder
Dosisoptimering og -begrundelse (Fase II): Areal under koncentrationstidskurven over tidsintervallet fra 0 til det sidste kvantificerbare datapunkt ved steady state (AUC0-tz,ss)
Tidsramme: op til 50 måneder
op til 50 måneder
Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss))
Tidsramme: up to 2 days

For cycle 2 only.
up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to 4h at steady state (AUC0-4h,ss)
Tidsramme: up to 2 days

For cycle 2 only.
up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Tidsramme: up to 2 days

For cycle 2 only.
up to 2 days
Dose optimization and justification (Phase II): Progression-free survival (PFS)
Tidsramme: up to 50 months

PFS is defined as the time from treatment start until the earliest date of tumor progression according RECIST 1.1 based on investigator review or death from any cause, whichever occurs first.
up to 50 months
Dose optimization and justification (Phase II): Disease control (DC)
Tidsramme: up to 50 months

DC is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by investigator review.
up to 50 months
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE
Tidsramme: up to 24 weeks

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library was developed to elicit symptomatic toxicity information directly from patients in cancer clinical trials. The items selected for this trial are: Mouth/throat sores, Taste changes, Decreased appetite, Nausea, Vomiting, Constipation, Diarrhoea, Shortness of breath, Cough, Rash, Skin dryness, Hair loss, Itching, Numbness & Tingling, Fatigue, Nosebleed, Headache.

PRO-CTCAE responses are scored from 0 (=none) to 4 (=very severe) (or 0/1 for absent/present).
up to 24 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46
Tidsramme: up to 48 weeks

The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
up to 48 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19
Tidsramme: up to 48 weeks

The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
up to 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. juni 2024

Primær færdiggørelse (Anslået)

8. januar 2029

Studieafslutning (Anslået)

8. januar 2029

Datoer for studieregistrering

Først indsendt

15. marts 2024

Først indsendt, der opfyldte QC-kriterier

15. marts 2024

Først opslået (Faktiske)

21. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1479-0012

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-delingsadgangskriterier

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner