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针对局部晚期或转移性尿路上皮癌参与者的研究 BT8009-230 (Duravelo-2)

2026年5月21日 更新者：BicycleTx Limited

BT8009 单药或联合治疗局部晚期或转移性尿路上皮癌受试者的随机开放标签 2/3 期研究 (Duravelo-2)

这是一项全球、多中心、随机、开放标签研究，采用适应性设计。 该研究的主要目的是衡量 BT8009 作为单一疗法以及与派姆单抗联合治疗局部晚期或转移性尿路上皮癌 (UC) 参与者的疗效和安全性。 该研究包括剂量选择阶段，随后是适应性设计延续。 该研究由 2 个队列组成。 第 1 组将包括未接受过任何局部晚期或转移性 UC 既往全身治疗且有资格接受铂类化疗的参与者，而第 2 组将包括先前接受过 ≥ 1 种局部晚期或转移性 UC 全身治疗的参与者。

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

375

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

主要纳入标准：

  • 预期寿命≥12周。
  • RECIST v1.1 定义的可测量疾病。
  • 经组织学或细胞学证实的肾盂、输尿管、膀胱或尿道局部晚期（不可切除）或转移性 UC。
  • 包含肌肉浸润性 UC 或局部晚期或转移性 UC 的档案或新鲜肿瘤组织应可提交给中心实验室。
  • 对育龄妇女进行阴性妊娠试验 (WOCBP)（筛查时血清检测呈阴性，首次给药前 72 小时内尿液或血清检测呈阴性）。
  • 第 1 组：以前未经治疗：有资格接受铂类化疗（根据研究者的决定，基于顺铂或卡铂的化疗。

  • 第 1 组：参与者之前不得接受过局部晚期或转移性 UC 的全身治疗，但以下情况除外：

    1. 如果在研究治疗开始前至少 4 周完成并且所有急性毒性均已解决，则允许既往进行局部膀胱内化疗、未实现完全切除时的局部手术、局部免疫治疗和放疗。
    2. 既往接受过新辅助/辅助化疗或基于单甲基阿里他汀 E (MMAE) 的治疗，且治疗完成后 12 个月以上出现复发。
    3. 既往接受过新辅助/辅助免疫检查点抑制剂治疗且治疗完成后 12 个月以上出现复发。
  • 第 2 组：既往接受过治疗：参与者之前必须接受过 ≥ 1 次局部晚期或转移性 UC 全身治疗。 如果完成治疗后 12 个月内发生复发，这包括新辅助/辅助铂类化疗。
  • 第 2 组：接受最近治疗期间或之后 UC 进展或复发。

主要排除标准：

  • 活动性角膜炎或角膜溃疡。
  • 研究期间需要使用人细胞色素 P450 3A (CYP3A) 的强抑制剂或强诱导剂或 P-糖蛋白 (P-gp) 抑制剂（包括草药或食物抑制剂）进行治疗。
  • 任何需要当前使用高剂量皮质类固醇（> 10 mg 每日泼尼松或等效物）治疗的病症。
  • 已知对任何研究干预措施的任何成分或 MMAE 过敏或过敏。
  • 尚未从最近的大手术中充分恢复（不包括血管通路的放置）。
  • 首次接种后 30 天内收到活疫苗或减毒疫苗。
  • 第 1 组：既往未接受治疗：在过去 12 个月内因任何其他恶性肿瘤接受过检查点抑制剂 (CPI) 治疗。
  • 第 2 组：既往接受过治疗：先前接受过 1 种以上的局部晚期或转移性 UC 铂类化疗方案。 如果完成治疗后 12 个月内发生复发，这包括新辅助/辅助铂类化疗。
  • 第 2 组：既往接受过 enfortumab vedotin 或任何其他基于 MMAE 的治疗

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：第 1 组：第 3 组
参与者将接受铂类联合化疗 +/- avelumab 维持治疗
药品：吉西他滨 + 顺铂 或 卡铂
参与者将在每个 21 天周期的第 1 天和第 8 天接受吉西他滨治疗，并在每个 21 天周期的第 1 天接受顺铂或卡铂治疗。
药品：阿维鲁布
吉西他滨 + 顺铂或卡铂 4-6 个周期后，如果有临床指征，参与者将在每个 28 天周期的第 1 天和第 15 天接受维持 Avelumab。
实验性的：Cohort 1: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
其他名称：
  • BT8009
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
其他名称：
  • BT8009
药品：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.
实验性的：Cohort 1: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
其他名称：
  • BT8009
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
其他名称：
  • BT8009
药品：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.
实验性的：Cohort 2: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin.
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
其他名称：
  • BT8009
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
其他名称：
  • BT8009
实验性的：Cohort 2: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin.
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
其他名称：
  • BT8009
药品：Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
其他名称：
  • BT8009

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：Up to approximately 4 years
Up to approximately 4 years

次要结果测量

结果测量
措施说明
大体时间
Cohort 1: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BicycleTx Limited

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月24日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2024年1月12日

首先提交符合 QC 标准的

2024年1月24日

首次发布 (实际的)

2024年1月26日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BT8009-230
  • 2023-504231-41 (EudraCT编号)
  • U1111-1300-3791 (其他标识符：UTN)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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