Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En fase 2-studie av Zanidatamab hos pasienter med HER2-uttrykkende svulster

2. november 2026 oppdatert av: Jazz Pharmaceuticals

En fase 2, åpen multisenterstudie for å evaluere effektiviteten og sikkerheten til Zanidatamab for behandling av deltakere med tidligere behandlede HER2-uttrykkende solide svulster (DiscovHER PAN-206)

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • Arizona
      • Prescott, Arizona, Forente stater, 86301
        • Tilbaketrukket
        • Arizona Oncology Associates, PC - NAHOA
    • Colorado
      • Littleton, Colorado, Forente stater, 80120
        • Rekruttering
        • Rocky Mountain Cancer Center
    • Florida
      • Fort Myers, Florida, Forente stater, 33901
        • Tilbaketrukket
        • Florida Cancer Specialists - South
      • Orlando, Florida, Forente stater, 32827
        • Aktiv, ikke rekrutterende
        • Florida Cancer Specialists - Lake Nona
      • St. Petersburg, Florida, Forente stater, 33705
        • Tilbaketrukket
        • Florida Cancer Specialists - North
      • West Palm Beach, Florida, Forente stater, 33401
        • Tilbaketrukket
        • Florida Cancer Specialists - East
    • Illinois
      • Chicago Ridge, Illinois, Forente stater, 60415
        • Tilbaketrukket
        • Affiliated Oncologists
    • Kansas
      • Westwood, Kansas, Forente stater, 66205
        • Rekruttering
        • University of Kansas Cancer Center
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Tilbaketrukket
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • Lake Success, New York, Forente stater, 11042
        • Rekruttering
        • Northwell Health Cancer Institute
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Horsham, Pennsylvania, Forente stater, 19044
        • Tilbaketrukket
        • Alliance Cancer Specialists
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Tilbaketrukket
        • Tennessee Cancer Specialists
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • SCRI Oncology Partners
    • Texas
      • Amarillo, Texas, Forente stater, 79124
        • Tilbaketrukket
        • Texas Oncology - West Texas
      • Dallas, Texas, Forente stater, 75246
        • Rekruttering
        • Texas Oncology - DFW
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
      • San Antonio, Texas, Forente stater, 78217
        • Tilbaketrukket
        • Texas Oncology - San Antonio
    • Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Tilbaketrukket
        • Blue Ridge Cancer Care
  • Georgia
      • Kutaisi, Georgia, 4600
        • Rekruttering
        • JSC Vian- Krystyna Kiel Oncology Center
      • Tbilisi, Georgia, 0144
        • Rekruttering
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
      • Tbilisi, Georgia, 0112
        • Rekruttering
        • LTD Todua Clinic
      • Tbilisi, Georgia, 0186
        • Rekruttering
        • Cancer Research Centre
      • Tbilisi, Georgia, 0186
        • Rekruttering
        • LTD Caucasus Medical Centre
  • Spania
      • Barcelona, Spania, 08035
        • Rekruttering
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spania, 08036
        • Rekruttering
        • Hospital Clinic de Barcelona
      • Madrid, Spania, 28034
        • Rekruttering
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spania, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
      • Málaga, Spania, 29010
        • Rekruttering
        • Hospital Regional Universitario de Malaga - Hospital General
      • Valencia, Spania, 46010
        • Rekruttering
        • INCLIVA, Hospital Clinico Universitario de Valencia
    • Las Palmas de Gran Canarias
      • Las Palmas, Las Palmas de Gran Canarias, Spania, 35016
        • Rekruttering
        • Hospital Universitario Insular Gran Canarias
    • Navarre
      • Pamplona, Navarre, Spania, 31008
        • Rekruttering
        • Complejo Hospitalario de Navarra
  • Sør -Korea
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center
      • Seoul, Sør -Korea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
      • Seoul, Sør -Korea, 04524
        • Rekruttering
        • The Catholic University of Korea Seoul St. Mary's Hospital
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Sør -Korea, 10408
        • Rekruttering
        • National Cancer Center Suwon
      • Suwon, Gyeonggi-do, Sør -Korea, 10408
        • Rekruttering
        • The Catholic University of Korea St Vincent's Hospital
    • Hwasun-Gun
      • Hwasun-Eup, Hwasun-Gun, Sør -Korea, 58115
        • Rekruttering
        • Chonnam National University Hwasun Hospital
    • Seoul
      • Gangnam-gu, Seoul, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
      • Guro-gu, Seoul, Sør -Korea, 04524
        • Rekruttering
        • Korea University Guro Hospital
      • Jongno-gu, Seoul, Sør -Korea, 03080
        • Rekruttering
        • Seoul National University Hospital
      • Seodaemun-gu, Seoul, Sør -Korea, 03722
        • Rekruttering
        • Severance Hospital

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:

  1. Is at least 18 years of age inclusive at the time of signing the informed consent

  2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.

  3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.

  4. All participants must have adequate tumor sample for submission to allow central HER2 testing.

  5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  7. Has a life expectancy of at least 3 months, in the opinion of the investigator.

  8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:

    1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
    2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to < Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1.
    3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.

  9. Adequate organ functions.

  10. Females of childbearing potential must have a negative pregnancy test result.

  11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Exclusion Criteria:

  1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
  2. Has uncontrolled or significant cardiovascular disease
  3. Has ongoing toxicity related to prior cancer therapy
  4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
  5. Has known Human Immunodeficiency Virus (HIV) infection.
  6. Has active hepatitis B or C infection.
  7. Has an active SARS-CoV-2 infection.
  8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
  9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
  10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.
  11. Prior treatment with HER2-targeted therapy (Cohort 1 only).
  12. Has a history of trauma or major surgery
  13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
  14. Received zanidatamab at any time prior to the current study.
  15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
  16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
  17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
  18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Zanidatamab treatment arm

Eligible participants receiving zanidatamab treatment
Legemiddel: Zanidatamab

Administered by intravenous (IV) infusion

Andre navn:
  • ZW25
  • JZP598
  • Ziihera®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
Tidsramme: Up to 2.5 years

The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to 2.5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere som rapporterer behandlingsfremkomne bivirkninger (TEAE) og alvorlige bivirkninger (SAE) som gradert av NCI CTCAE versjon 5.0
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Antall deltakere med dosereduksjoner
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Antall deltakere som avbryter studiebehandling på grunn av TEAE
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Serumkonsentrasjoner av Zanidatamab
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Antall deltakere positive for anti-legemiddelantistoffer mot Zanidatamab
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Antall deltakere som rapporterer symptomatiske bivirkninger basert på pasientrapportert utfall-felles terminologikriterier for AE (PRO-CTCAE)
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Antall deltakere som rapporterer symptomatiske uønskede hendelser basert på European Organization for Research and Treatment of Cancer (EORTC) Item Library
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Prosentandel av alle behandlede deltakere som rapporterer generelle bivirkningsplager i funksjonsvurderingen av kronisk sykdomsterapi Generelt fysisk punkt 5 (FACIT-GP5)
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Prosentandel av tid da deltakere på behandling rapporterte en høy bivirkningsplager på Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR
Tidsramme: Up to 2.5 years

ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.
Up to 2.5 years
cORR by RECIST Version 1.1, as assessed by Investigator
Tidsramme: Up to 2.5 years

Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to 2.5 years
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator
Tidsramme: Up to 2.5 years

Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.
Up to 2.5 years
Time to Response (TTR), as assessed by ICR
Tidsramme: Up to 2.5 years

ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1.
Up to 2.5 years
Time to Response (TTR), as assessed by Investigator
Tidsramme: Up to 2.5 years

Investigator assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1.
Up to 2.5 years
Disease control rate (DCR), as assessed by ICR
Tidsramme: Up to 2.5 years

ICR assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria
Up to 2.5 years
Disease control rate (DCR), as assessed by Investigator
Tidsramme: Up to 2.5 years

Investigator assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria
Up to 2.5 years
Progression Free Survival (PFS), as assessed by ICR
Tidsramme: Up to 2.5 years

PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by ICR according to RECIST v1.1) or death from any cause, whichever occurs first.
Up to 2.5 years
Progression Free Survival (PFS), as assessed by Investigator
Tidsramme: Up to 2.5 years

PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by Investigator according to RECIST v1.1) or death from any cause, whichever occurs first.
Up to 2.5 years
Overall Survival (OS)
Tidsramme: Up to 3.5 years

OS is defined as the time in months from the first dosing date to the date of death due to any cause.
Up to 3.5 years

Samarbeidspartnere og etterforskere

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

Sponsor

Jazz Pharmaceuticals

Samarbeidspartnere

Jazz Pharmaceuticals Ireland Limited

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)

14. januar 2025

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

16. november 2024

Først innsendt som oppfylte QC-kriteriene

16. november 2024

Først lagt ut (Faktiske)

19. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • JZP598-206
  • 2024-516551-41-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

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