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Undersøg BT8009-230 i deltagere med lokalt avanceret eller metastatisk urinrørskræft (Duravelo-2)

21. maj 2026 opdateret af: BicycleTx Limited

Et randomiseret åbent fase 2/3-studie af BT8009 som monoterapi eller i kombination hos deltagere med lokalt avanceret eller metastatisk urothelial cancer (Duravelo-2)

Dette er et globalt, multicenter, randomiseret, åbent studie med et adaptivt design. Hovedformålet med studiet er at måle effektiviteten og sikkerheden af ​​BT8009 som monoterapi og i kombination med pembrolizumab hos deltagere med lokalt fremskreden eller metastatisk urotelcancer (UC). Undersøgelsen omfatter en dosisudvælgelsesfase efterfulgt af en adaptiv designfortsættelse. Undersøgelsen består af 2 kohorter. Kohorte 1 vil omfatte deltagere, der ikke har modtaget nogen tidligere systemisk terapi for lokalt fremskreden eller metastatisk UC og er berettiget til at modtage platinbaseret kemoterapi, hvorimod kohorte 2 vil omfatte deltagere, der har modtaget ≥ 1 tidligere systemisk behandling for lokalt fremskreden eller metastatisk UC.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

375

Fase

  • Fase 2

Kontakter og lokationer

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

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 Cancer
      • 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.
  • Australien
      • Adelaide, Australien, 5000
        • Cancer Research SA
      • Brisbane, Australien, 4101
        • Mater Misericordiae Ltd, South Brisbane
      • Douglas, Australien, QLD 4814
        • Townsville Hospital and Health Service
      • Geelong, Australien, 3220
        • Barwon Health
      • Hunter, Australien, 2310
        • Calvary Mater Newcastle
      • Nedlands, Australien, 6009
        • Sir Charles Gairdner Hospital
      • New South Wales, Australien, 2148
        • Blacktown Hospital
      • South Brisbane, Australien, 4066
        • Icon Cancer Centre
      • Southport, Australien, 4215
        • Gold Coast University Hospital
  • Belgien
      • Ghent, Belgien, 9000
        • General Hospital Maria Middelares
      • Ghent, Belgien, 9000
        • University Hospital Gent
  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Fundacao PIO XII - Hospital de Amor
      • Florianópolis, Brasilien, 88020-210
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
      • São Paulo, Brasilien, 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
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, Det Forenede Kongerige, CB2 0QQ
        • Addenbrooke's Hospital
      • London, Det Forenede Kongerige, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, Det Forenede Kongerige, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, Det Forenede Kongerige, NW1 2PG
        • University College London Hospital
      • Plymouth, Det Forenede Kongerige, PL6 8DH
        • Derriford Hospital
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • The Royal Marsden Hospital
  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Center of Florida, Inc.
      • Tampa, Florida, Forenede Stater, 33612
        • Moffitt
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • UofL Health Brown Cancer Center
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • Nebraska Cancer Specialists
    • New York
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina (MUSC) - Hollings Cancer Center
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Scri Oncology Partners
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Science Center at San Antonio
  • Frankrig
      • Besançon, Frankrig, 25000
        • Service d'Oncologie Medicale - CHRU Besancon
      • Bordeaux, Frankrig, 33000
        • CHU Bordeaux - Hopital Saint-Andre
      • Le Mans, Frankrig, 72000
        • Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
      • Pierre-Bénite, Frankrig, 69495
        • HCL Centre Hospitalier Lyon Sud
      • Villejuif, Frankrig, 94805
        • Institut Gustave Roussy
  • Georgien
      • Batumi, Georgien, 6000
        • LTD High Technology Hospital Medcenter
      • Tbilisi, Georgien, 0141
        • The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Georgien, 0159
        • New Vision University Hospital
      • Tbilisi, Georgien, 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
  • Italien
      • Aviano, Italien, 33081
        • Centro Riferimento Oncologico - Aviano
      • Genova, Italien, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Naples, Italien, 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
  • Serbien
      • Belgrade, Serbien, 11000
        • University Clinical Center of Serbia, Clinic of Urology
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spanien, 08026
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spanien, 08908
        • Institut Català d'Oncologia - L'Hospitalet
      • Las Palmas de Gran Canaria, Spanien, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spanien, 28027
        • Clínica Universidad de Navarra - Madrid
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spanien, 28040
        • Hospital Fundación Jiménez Díaz
      • Pamplona, Spanien, 31008
        • Clinica Universidad de Navarra - Pamplona
      • San Sebastián, Spanien, 20014
        • Hospital Universitario Donostia
      • Santander, Spanien, 39008
        • Hospital Universitario Marques de Valdecilla
      • Santiago de Compostela, Spanien, 15706
        • Hospital Clinico Universitario de Santiago
      • Valencia, Spanien, 46009
        • Instituto Valenciano de Oncologia
  • Sydkorea
      • Daejeon, Sydkorea, 35015
        • Chungnam National University Hospital
      • Goyang, Sydkorea, 10408
        • National Cancer Center
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Sydkorea, 02841
        • Korea University Anam Hospital
      • Seoul, Sydkorea, 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)
  • Tyrkiet (Türkiye)
      • Edirne, Tyrkiet (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Tyrkiet (Türkiye), 34899
        • Istinye Universitesi VM Medical Park Pendik Hastanesi
      • Izmir, Tyrkiet (Türkiye), 35575
        • Medical Point Izmir Hospital
      • Kocaeli, Tyrkiet (Türkiye), 41380
        • Kocaeli University Faculty of Medicine
  • Tyskland
      • Essen, Tyskland, 45147
        • Universitaetsklinikum Essen
  • Ungarn
      • Budapest, Ungarn, H-1122
        • Országos Onkológiai Intézet
      • Budapest, Ungarn, H-1145
        • Budapesti Uzsoki Utcai Kórház

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

  • Forventet levetid ≥ 12 uger.
  • Målbar sygdom som defineret af RECIST v1.1.
  • Histologisk eller cytologisk bekræftet lokalt fremskreden (ikke-opererbar) eller metastatisk UC i nyrebækkenet, urinlederen, blæren eller urinrøret.
  • Arkiveret eller frisk tumorvæv omfattende muskelinvasiv UC eller lokalt fremskreden eller metastatisk UC bør være tilgængelig for indsendelse til centrallaboratorium.
  • Negativ graviditetstest for kvinder i den fødedygtige alder (WOCBP) (negativ serumtest ved screening og negativ urin- eller serumtest inden for 72 timer før første dosis).
  • Kohorte 1: Tidligere ubehandlet: Berettiget til at modtage platinbaseret kemoterapi (enten cisplatin- eller carboplatin-baseret kemoterapi baseret på investigators beslutning.

  • Kohorte 1: Deltagerne må ikke have modtaget forudgående systemisk behandling for lokalt fremskreden eller metastatisk UC med følgende undtagelser:

    1. Forudgående lokal intravesikal kemoterapi, lokal kirurgi, når fuld resektion ikke er opnået, lokal immunterapi og strålebehandling er tilladt, hvis afsluttet mindst 4 uger før påbegyndelse af undersøgelsesbehandling, og alle akutte toksiciteter er forsvundet.
    2. Forudgående neoadjuverende/adjuverende kemoterapi eller monomethylauristatin E (MMAE)-baseret behandling med recidiv >12 måneder efter afslutning af behandlingen.
    3. Forudgående neoadjuverende/adjuverende immuncheckpoint-hæmmerbehandling med recidiv >12 måneder fra afslutning af behandlingen.
  • Kohorte 2: Tidligere behandlet: Deltagerne skal have modtaget ≥ 1 tidligere systemisk behandling for lokalt fremskreden eller metastatisk UC. Dette inkluderer neoadjuverende/adjuverende platinbaseret kemoterapi, hvis recidiv opstod inden for 12 måneder efter afsluttet behandling.
  • Kohorte 2: Progression eller tilbagevenden af ​​UC under eller efter modtagelse af seneste behandling.

Nøgleekskluderingskriterier:

  • Aktiv keratitis eller hornhindeulcerationer.
  • Krav til behandling med stærke hæmmere eller stærke inducere af human cytochrom P450 3A (CYP3A) eller hæmmere af P-glycoprotein (P-gp) inklusive urte- eller fødevarebaserede hæmmere, mens de er under undersøgelse.
  • Enhver tilstand, der kræver aktuel behandling med højdosis kortikosteroider (> 10 mg dagligt prednison eller tilsvarende).
  • Kendt overfølsomhed eller allergi over for nogen af ​​ingredienserne i nogen af ​​undersøgelsesinterventionerne eller over for MMAE.
  • Er ikke kommet sig tilstrækkeligt efter nylig større operation (eksklusive placering af vaskulær adgang).
  • Modtagelse af levende eller svækket vaccine inden for 30 dage efter første dosis.
  • Kohorte 1: Tidligere ubehandlet: Forudgående behandling med en checkpoint inhibitor (CPI) for enhver anden malignitet inden for de sidste 12 måneder.
  • Kohorte 2: Tidligere behandlet: Modtaget mere end 1 tidligere platinbaseret kemoterapiregime for lokalt fremskreden eller metastatisk UC. Dette inkluderer neoadjuverende/adjuverende platinbaseret kemoterapi, hvis recidiv opstod inden for 12 måneder efter afsluttet behandling.
  • Kohorte 2: Tidligere behandling med enfortumab vedotin eller enhver anden MMAE-baseret behandling

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
Aktiv komparator: Kohorte 1: Arm 3
Deltagerne vil modtage platinbaseret kombinationskemoterapi +/- avelumab vedligeholdelse
Medicin: Gemcitabin + cisplatin Eller carboplatin
Deltagerne vil modtage Gemcitabin på dag 1 og 8 i hver 21-dages cyklus plus cisplatin eller carboplatin på dag 1 i hver 21-dages cyklus.
Medicin: Avelumab
Efter 4-6 cyklusser med Gemcitabin + Cisplatin eller Carboplatin vil deltagerne modtage vedligeholdelses-Avelumab, hvis det er klinisk indiceret, på dag 1 og 15 hver 28-dages cyklus.
Eksperimentel: Cohort 1: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: 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.
Eksperimentel: Cohort 1: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: 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.
Eksperimentel: Cohort 2: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin.
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navne:
  • BT8009
Eksperimentel: Cohort 2: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin.
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Andre navne:
  • BT8009
Medicin: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Andre navne:
  • BT8009

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

BicycleTx Limited

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)

24. januar 2024

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

12. januar 2024

Først indsendt, der opfyldte QC-kriterier

24. januar 2024

Først opslået (Faktiske)

26. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

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