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Beamion BCGC-1: En studie for å finne en passende dose av Zongertinib i kombinasjon med Trastuzumab Deruxtecan eller Trastuzumab Emtansine og for å teste om det hjelper mennesker med forskjellige typer HER2+ kreft som har spredt seg

3. november 2026 oppdatert av: Boehringer Ingelheim

Beamion BCGC-1: En fase Ib-doseeskalering og fase II-doseoptimalisering, randomisert, åpen, multisenterforsøk av oral Zongertinib (BI 1810631) i kombinasjon med intravenøs trastuzumab deruxtecan (T-DXd) eller i kombinasjon med intravenøs emtanstuz T-DM1) for behandling av pasienter med avansert HER2+ metastatisk brystkreft (mBC) og metastatisk gastrisk, gastroøsofageal Junction eller Esophageal Adenocarcinoma (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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

910

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab emtansine

Trastuzumab emtansine

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

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab deruxtecan

Trastuzumab deruxtecan

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

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab deruxtecan

Trastuzumab deruxtecan

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

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab emtansine

Trastuzumab emtansine

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

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab deruxtecan

Trastuzumab deruxtecan

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

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab deruxtecan

Trastuzumab deruxtecan

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

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Legemiddel: Capecitabine

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

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Eksperimentell: Phase II - Cohort H: zongertinib + trastuzumab + capecitabine

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Legemiddel: Capecitabine

Capecitabine
Eksperimentell: Phase II - Cohort I: zongertinib

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

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

Dose optimization (Phase II).
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Eksperimentell: Phase II - Cohort I-ext: zongertinib

Extension Phase II
Legemiddel: Zongertinib

Zongertinib

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

Extension Phase II
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Eksperimentell: Phase Ib - Cohort M: zongertinib + mFOLFOX6

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: mFOLFOX6

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

Dose escalation (Phase Ib)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Legemiddel: mFOLFOX6

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

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

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: zanidatamab

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

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

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: zanidatamab

zanidatamab

Legemiddel: Docetaxel

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

Dose justification (Phase II)
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®
Eksperimentell: Phase II - Cohort L-ext: zongertinib + trastuzumab

Extension Phase II
Legemiddel: Zongertinib

Zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Legemiddel: Trastuzumab

Trastuzumab

Andre navn:
  • Herceptin®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Doseeskalering (fase Ib): Objektiv respons (OR)
Tidsramme: opptil 50 måneder
opptil 50 måneder
Doseeskalering (fase Ib): Forekomst av dosebegrensende toksisiteter (DLT) under hele behandlingsperioden
Tidsramme: opptil 50 måneder
opptil 50 måneder
Doseoptimalisering og begrunnelse (fase II): Forekomst av behandlingsrelaterte bivirkninger som fører til dose-reduksjon av zongertinib (BI 1810631) i løpet av behandlingsperioden
Tidsramme: opptil 50 måneder
opptil 50 måneder
Doseoptimalisering og -begrunnelse (Fase II): Maksimalt målt konsentrasjon (ved stabil tilstand) (Cmax,(ss))
Tidsramme: opptil 50 måneder
opptil 50 måneder
Doseoptimalisering og begrunnelse (fase II): Areal under konsentrasjon–tids-kurven over tidsintervallet fra 0 til det siste kvantifiserbare datapunktet ved likevektstilstand (AUC0-tz,ss)
Tidsramme: opptil 50 måneder
opptil 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. juni 2024

Primær fullføring (Antatt)

8. januar 2029

Studiet fullført (Antatt)

8. januar 2029

Datoer for studieregistrering

Først innsendt

15. mars 2024

Først innsendt som oppfylte QC-kriteriene

15. mars 2024

Først lagt ut (Faktiske)

21. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1479-0012

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere