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Studie BT8009-230 hos deltakere med lokalt avansert eller metastatisk urotelkreft (Duravelo-2)

21. mai 2026 oppdatert av: BicycleTx Limited

En randomisert åpen fase 2/3-studie av BT8009 som monoterapi eller i kombinasjon hos deltakere med lokalt avansert eller metastatisk urotelkreft (Duravelo-2)

Dette er en global, multisenter, randomisert, åpen studie, med et adaptivt design. Hovedmålet med studien er å måle effekt og sikkerhet av BT8009 som monoterapi og i kombinasjon med pembrolizumab hos deltakere med lokalt avansert eller metastatisk urotelial kreft (UC). Studien inkluderer en dosevalgsfase etterfulgt av en adaptiv design fortsettelse. Studiet består av 2 kohorter. Kohort 1 vil inkludere deltakere som ikke har mottatt noen tidligere systemisk terapi for lokalt avansert eller metastatisk UC og er kvalifisert til å motta platinabasert kjemoterapi, mens kohort 2 vil inkludere deltakere som har mottatt ≥ 1 tidligere systemisk terapi for lokalt avansert eller metastatisk UC.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

375

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1120AAT
        • Centro de Diagnostico Urologico S.R.L.
      • Buenos Aires, Argentina, C1419AHN
        • Hospital Sirio Libanes de Buenos Aires
      • Cipolletti, Argentina, R8324
        • Fundacion Medica Rio Negro y Neuquen
      • Córdoba, Argentina, X5008HHW
        • Centro Medico Privado (CEMAIC)
      • La Rioja, Argentina, 5300
        • Fundación CORI para la Investigación y Prevención del Cáncer
      • Pergamino, Argentina, B2700CPM
        • Centro de Investigacion Pergamino S.A.
      • Santa Fe, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
      • Viedma, Argentina, 8500
        • Clinica Viedma S.A.
  • Australia
      • Adelaide, Australia, 5000
        • Cancer Research SA
      • Brisbane, Australia, 4101
        • Mater Misericordiae Ltd, South Brisbane
      • Douglas, Australia, QLD 4814
        • Townsville Hospital and Health Service
      • Geelong, Australia, 3220
        • Barwon Health
      • Hunter, Australia, 2310
        • Calvary Mater Newcastle
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • New South Wales, Australia, 2148
        • Blacktown Hospital
      • South Brisbane, Australia, 4066
        • Icon Cancer Centre
      • Southport, Australia, 4215
        • Gold Coast University Hospital
  • Belgia
      • Ghent, Belgia, 9000
        • General Hospital Maria Middelares
      • Ghent, Belgia, 9000
        • University Hospital Gent
  • Brasil
      • Barretos, Brasil, 14784-400
        • Fundacao PIO XII - Hospital de Amor
      • Florianópolis, Brasil, 88020-210
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
      • São Paulo, Brasil, 01327-001
        • Hospital Alemao Oswaldo Cruz
  • Canada
      • Québec, Canada, H4A 3J1
        • McGill University Health Center
      • Toronto, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Chile
      • Santiago, Chile, 7500921
        • Fundación Arturo López Pérez (FALP)
      • Santiago, Chile, 8420000
        • Centro de Investigacion Clinica Bradford Hill
      • Viña del Mar, Chile, 2520598
        • Oncocentro Apys
  • Forente stater
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Miami, Florida, Forente stater, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center
      • Miami Beach, Florida, Forente stater, 33140
        • Mount Sinai Medical Center of Florida, Inc.
      • Tampa, Florida, Forente stater, 33612
        • Moffitt
    • Kansas
      • Westwood, Kansas, Forente stater, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • UofL Health Brown Cancer Center
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68130
        • Nebraska Cancer Specialists
    • New York
      • The Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina (MUSC) - Hollings Cancer Center
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center at San Antonio
  • Frankrike
      • Besançon, Frankrike, 25000
        • Service d'Oncologie Medicale - CHRU Besancon
      • Bordeaux, Frankrike, 33000
        • CHU Bordeaux - Hopital Saint-Andre
      • Le Mans, Frankrike, 72000
        • Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
      • Pierre-Bénite, Frankrike, 69495
        • HCL Centre Hospitalier Lyon Sud
      • Villejuif, Frankrike, 94805
        • Institut Gustave Roussy
  • Georgia
      • Batumi, Georgia, 6000
        • LTD High Technology Hospital Medcenter
      • Tbilisi, Georgia, 0141
        • The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Georgia, 0159
        • New Vision University Hospital
      • Tbilisi, Georgia, 0186
        • Multiprofile Clinic Consilium Medulla LTD
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah Hebrew University Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center - Beilinson Hospital
  • Italia
      • Aviano, Italia, 33081
        • Centro Riferimento Oncologico - Aviano
      • Genova, Italia, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Naples, Italia, 80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
  • Polen
      • Gdansk, Polen, 80-210
        • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
      • Wieliszew, Polen, 05-135
        • Mazowiecki Szpital Onkologiczny
  • Serbia
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia, Clinic of Urology
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • Spania
      • Barcelona, Spania, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spania, 08026
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spania, 08908
        • Institut Català d'Oncologia - L'Hospitalet
      • Las Palmas de Gran Canaria, Spania, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spania, 28027
        • Clínica Universidad de Navarra - Madrid
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
      • Madrid, Spania, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spania, 28040
        • Hospital Fundación Jiménez Díaz
      • Pamplona, Spania, 31008
        • Clinica Universidad de Navarra - Pamplona
      • San Sebastián, Spania, 20014
        • Hospital Universitario Donostia
      • Santander, Spania, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Santiago de Compostela, Spania, 15706
        • Hospital Clinico Universitario de Santiago
      • Valencia, Spania, 46009
        • Instituto Valenciano de Oncología
  • Storbritannia
      • Bristol, Storbritannia, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, Storbritannia, CB2 0QQ
        • Addenbrooke's Hospital
      • London, Storbritannia, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, Storbritannia, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, Storbritannia, NW1 2PG
        • University College London Hospital
      • Plymouth, Storbritannia, PL6 8DH
        • Derriford Hospital
      • Sutton, Storbritannia, SM2 5PT
        • The Royal Marsden Hospital
  • Sør -Korea
      • Daejeon, Sør -Korea, 35015
        • Chungnam national university hospital
      • Goyang, Sør -Korea, 10408
        • National Cancer Center
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center
      • Seoul, Sør -Korea, 06351
        • Samsung Medical Center
      • Seoul, Sør -Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Sør -Korea, 3722
        • Severance Hospital, Yonsei University Health System
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
  • Tyrkia (Türkiye)
      • Edirne, Tyrkia (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Tyrkia (Türkiye), 34899
        • Istinye Universitesi VM Medical Park Pendik Hastanesi
      • Izmir, Tyrkia (Türkiye), 35575
        • Medical Point Izmir Hospital
      • Kocaeli, Tyrkia (Türkiye), 41380
        • Kocaeli University Faculty of Medicine
  • Tyskland
      • Essen, Tyskland, 45147
        • Universitaetsklinikum Essen
  • Ungarn
      • Budapest, Ungarn, H-1122
        • Orszagos Onkologiai Intezet
      • Budapest, Ungarn, H-1145
        • Budapesti Uzsoki Utcai Kórház

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Viktige inkluderingskriterier:

  • Forventet levealder ≥ 12 uker.
  • Målbar sykdom som definert av RECIST v1.1.
  • Histologisk eller cytologisk bekreftet lokalt avansert (ikke-opererbar) eller metastatisk UC i nyrebekkenet, urinlederen, blæren eller urinrøret.
  • Arkivert eller ferskt tumorvev som omfatter muskelinvasiv UC eller lokalt avansert eller metastatisk UC bør være tilgjengelig for innsending til sentrallaboratorium.
  • Negativ graviditetstest for kvinner i fertil alder (WOCBP) (negativ serumtest ved screening og negativ urin- eller serumtest innen 72 timer før første dose).
  • Kohort 1: Tidligere ubehandlet: Kvalifisert til å motta platinabasert kjemoterapi (enten cisplatin- eller karboplatinbasert kjemoterapi basert på etterforskerens beslutning.

  • Kohort 1: Deltakerne må ikke ha mottatt tidligere systemisk terapi for lokalt avansert eller metastatisk UC med følgende unntak:

    1. Forutgående lokal intravesikal kjemoterapi, lokal kirurgi når full reseksjon ikke er oppnådd, lokal immunterapi og strålebehandling er tillatt dersom den er fullført minst 4 uker før oppstart av studiebehandlingen og alle akutte toksisiteter er forsvunnet.
    2. Tidligere neoadjuvant/adjuvant kjemoterapi eller monometylauristatin E (MMAE)-basert behandling med tilbakefall >12 måneder fra avsluttet behandling.
    3. Tidligere neoadjuvant/adjuvant immunsjekkpunkthemmerbehandling med tilbakefall >12 måneder fra avsluttet behandling.
  • Kohort 2: Tidligere behandlet: Deltakerne må ha mottatt ≥ 1 tidligere systemisk behandling for lokalt avansert eller metastatisk UC. Dette inkluderer neoadjuvant/adjuvant platinabasert kjemoterapi dersom tilbakefall oppstod innen 12 måneder etter avsluttet behandling.
  • Kohort 2: Progresjon eller tilbakefall av UC under eller etter mottak av siste behandling.

Nøkkelekskluderingskriterier:

  • Aktiv keratitt eller hornhinnesår.
  • Krav, under studiet, for behandling med sterke hemmere eller sterke induktorer av humant cytokrom P450 3A (CYP3A) eller hemmere av P-glykoprotein (P-gp) inkludert urte- eller matbaserte inhibitorer.
  • Enhver tilstand som krever nåværende behandling med høydose kortikosteroider (> 10 mg daglig prednison eller tilsvarende).
  • Kjent overfølsomhet eller allergi mot noen av ingrediensene i noen av studieintervensjonene, eller mot MMAE.
  • Har ikke kommet seg tilstrekkelig etter nylig større operasjon (unntatt plassering av vaskulær tilgang).
  • Mottak av levende eller svekket vaksine innen 30 dager etter første dose.
  • Kohort 1: Tidligere ubehandlet: Tidligere behandling med en sjekkpunkthemmer (CPI) for annen malignitet i løpet av de siste 12 månedene.
  • Kohort 2: Tidligere behandlet: Fikk mer enn 1 tidligere platinabasert kjemoterapiregime for lokalt avansert eller metastatisk UC. Dette inkluderer neoadjuvant/adjuvant platinabasert kjemoterapi dersom tilbakefall oppstod innen 12 måneder etter avsluttet behandling.
  • Kohort 2: Tidligere behandling med enfortumab vedotin eller annen MMAE-basert terapi

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
Aktiv komparator: Kohort 1: Arm 3
Deltakerne vil motta platinabasert kombinasjonskjemoterapi +/- vedlikehold av avelumab
Legemiddel: Gemcitabin + cisplatin Eller karboplatin
Deltakerne vil motta Gemcitabin på dag 1 og 8 i hver 21-dagers syklus pluss cisplatin eller karboplatin på dag 1 i hver 21-dagers syklus.
Legemiddel: Avelumab
Etter 4-6 sykluser med Gemcitabin + Cisplatin eller Carboplatin vil deltakerne motta vedlikehold av Avelumab, hvis klinisk indisert, på dag 1 og 15 hver 28-dagers syklus.
Eksperimentell: Cohort 1: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion.
Eksperimentell: Cohort 1: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion.
Eksperimentell: Cohort 2: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin.
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navn:
  • BT8009
Eksperimentell: Cohort 2: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin.
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navn:
  • BT8009
Legemiddel: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navn:
  • BT8009

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST v1.1) by blinded central independent review (BICR) of optimal dose zelenectide pevedotin with pembrolizumab versus chemotherapy
Tidsramme: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 2: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen
Tidsramme: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 2: Objective response rate (ORR) per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen
Tidsramme: Up to approximately 4 years
Up to approximately 4 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy
Tidsramme: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy.
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Cohort 1: Overall survival (OS) rate of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy
Tidsramme: Up to approximately 4 years
The time from randomization to date of death from any cause.
Up to approximately 4 years
Cohort 1: Duration of response (DoR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab
Tidsramme: Up to approximately 4 years
The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: Disease control rate (DCR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab
Tidsramme: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: PFS per RECIST v1.1 assessed by BICR of unselected zelenectide pevedotin dose in combination with pembrolizumab
Tidsramme: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: OS rate of zelenectide pevedotin combined treatment arms in combination with pembrolizumab versus chemotherapy
Tidsramme: Up to approximately 4 years
The time from randomization to date of death from any cause
Up to approximately 4 years
Cohort 2: DoR per RECIST v1.1 assessed by BICR in each treatment regimen
Tidsramme: Up to approximately 4 years
The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 2: DCR per RECIST v1.1 assessed by BICR in each treatment regimen
Tidsramme: Up to approximately 4 years
The time from cycle 1 Day 1 to date of first documentation of disease progression or death
Up to approximately 4 years
Cohort 2: OS rate in each treatment regimen
Tidsramme: Up to approximately 4 years
The time from randomization to date of death from any cause
Up to approximately 4 years
Cohorts 1 and 2: Safety and tolerability of each treatment regimen
Tidsramme: Until 30 days post last dose, up to approximately 4 years
Safety will be reported as incidence, severity, seriousness, relationship to study and types of adverse events
Until 30 days post last dose, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin area under the plasma concentration-time curve (AUC)
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin pharmacokinetic (PK) parameter (AUC) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin AUC
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for monomethyl auristatin (MMAE) AUC
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE AUC
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin maximum plasma concentration (Cmax)
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cmax
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin average plasma concentration (Cavg)
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cavg
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin AUC
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE AUC
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cmax
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE Cmax
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cavg
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Exposure-safety relationships for MMAE Cavg
Tidsramme: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years

Samarbeidspartnere og etterforskere

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

Sponsor

BicycleTx 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)

24. januar 2024

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

12. januar 2024

Først innsendt som oppfylte QC-kriteriene

24. januar 2024

Først lagt ut (Faktiske)

26. januar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BT8009-230
  • 2023-504231-41 (EudraCT-nummer)
  • U1111-1300-3791 (Annen identifikator: UTN)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

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