一项关于PF-08634404研究药物联合不同抗癌药物治疗晚期癌症的研究
一项干预性开放标签1B/2期研究，旨在评估PF-08634404联合不同抗癌药物治疗晚期实体瘤患者的安全性、药代动力学及初步疗效
This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.
To join in the study, participants must:
- Be 18 years or older
- Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body
The study will look at:
- Whether PF-08634404 is safe to use with other cancer medicines.
- What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
- Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
- Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
- Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V
Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Pfizer CT.gov Call Center
- 电话号码：1-800-718-1021
- 邮箱：ClinicalTrials.gov_Inquiries@pfizer.com
学习地点
-
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Beijing Municipality
-
Beijing、Beijing Municipality、中国、100730
- 招聘中
- Peking Union Medical College Hospital
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Beijing、Beijing Municipality、中国、100142
- 招聘中
- Beijing Cancer hospital
-
-
Fujian
-
Fuzhou、Fujian、中国、350014
- 招聘中
- Fujian Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- 招聘中
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 尚未招聘
- Jiangsu Province Hospital
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200032
- 尚未招聘
- Fudan University Shanghai Cancer Center
-
Shanghai、Shanghai Municipality、中国、200030
- 招聘中
- Shanghai Chest Hospital
-
-
Zhejiang
-
Taizhou、Zhejiang、中国、317000
- 招聘中
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Kaohsiung City、台湾、807
- 招聘中
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City、台湾、83301
- 招聘中
- Chang Gung Memorial Hospital at Kaohsiung
-
Tainan、台湾、704
- 招聘中
- National Cheng Kung University Hospital
-
Taipei、台湾、100
- 招聘中
- National Taiwan University Hospital
-
Taipei、台湾、10449
- 招聘中
- Mackay Memorial Hospital
-
Taipei、台湾、11217
- 招聘中
- Taipei Veterans General Hospital
-
-
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau、Baden-Wurttemberg、德国、79106
- 招聘中
- Universitaetsklinikum Freiburg
-
-
Hesse
-
Frankfurt am Main、Hesse、德国、60488
- 招聘中
- Krankenhaus Nordwest GmbH
-
-
North Rhine-Westphalia
-
Düsseldorf、North Rhine-Westphalia、德国、40479
- 招聘中
- Marien Hospital Düsseldorf
-
-
-
-
Pesaro AND Urbino
-
Fano、Pesaro AND Urbino、意大利、61032
- 尚未招聘
- Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
-
-
ROME
-
Roma、ROME、意大利、00144
- 尚未招聘
- IRCCS Istituto Nazionale dei Tumori Regina Elena
-
Roma、ROME、意大利、00186
- 尚未招聘
- Ospedale Isola Tiberina - Gemelli Isola
-
-
-
-
Chiba
-
Kashiwa、Chiba、日本、277-8577
- 招聘中
- National Cancer Center Hospital East
-
-
Miyagi
-
Sendai、Miyagi、日本、9810914
- 尚未招聘
- Sendai Kousei Hospital
-
-
Osaka
-
Hirakata、Osaka、日本、573-1191
- 招聘中
- Kansai Medical University Hospital
-
-
Shizuoka
-
Nagaizumi-cho、Shizuoka、日本、411-8777
- 招聘中
- Shizuoka Cancer Center
-
-
Tokyo
-
Bunkyo-ku、Tokyo、日本、113-8677
- 招聘中
- Tokyo Metropolitan Komagome Hospital
-
Bunkyo-ku、Tokyo、日本、113-8603
- 尚未招聘
- Nippon Medical School Hospital
-
-
-
-
Aquitaine
-
Bordeaux、Aquitaine、法国、33076
- 招聘中
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
-
-
CÔTE D'OR
-
Dijon、CÔTE D'OR、法国、21079
- 招聘中
- Centre Georges François Leclerc
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille、Provence-Alpes-Côte d'Azur Region、法国、13273
- 招聘中
- Institut Paoli-Calmettes
-
-
Île-de-France Region
-
Paris、Île-de-France Region、法国、75014
- 招聘中
- Groupe hospitalier Paris saint Joseph
-
-
-
-
-
Mayagüez、波多黎各、00680
- 招聘中
- Pan American Center for Oncology Trials, LLC - Mayaguez
-
Rio Piedras、波多黎各、00935
- 招聘中
- Pan American Center for Oncology Trials, LLC
-
San Juan、波多黎各、00917
- 招聘中
- BRCR Global Puerto Rico - Hato Rey
-
-
-
-
Arkansas
-
Fayetteville、Arkansas、美国、72703
- 招聘中
- Highlands Oncology Group, PA
-
Rogers、Arkansas、美国、72758
- 招聘中
- Highlands Oncology Group, PA
-
Springdale、Arkansas、美国、72762
- 招聘中
- Highlands Oncology Group, PA
-
-
California
-
Fullerton、California、美国、92835
- 招聘中
- Providence Medical Foundation
-
Fullerton、California、美国、92835
- 招聘中
- Providence St. Jude Medical Center
-
Fullerton、California、美国、92835
- 招聘中
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
-
La Jolla、California、美国、92037
- 招聘中
- Scripps Green Hospital
-
La Jolla、California、美国、92037
- 招聘中
- Scripps Clinic Torrey Pines (Scripps Cancer Center)
-
La Jolla、California、美国、92037
- 招聘中
- Scripps Shiley Pavilion
-
Los Angeles、California、美国、90067
- 招聘中
- Valkyrie Clinical Trials
-
Los Angeles、California、美国、90025
- 招聘中
- START Los Angeles, LLC
-
Los Angeles、California、美国、90067
- 招聘中
- Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)
-
Los Angeles、California、美国、90067
- 招聘中
- LACN Century City
-
Los Angeles、California、美国、90067
- 招聘中
- Valkyrie Clinical Trials (Additional Site Suite)
-
Panorama City、California、美国、91402
- 招聘中
- Mission Community Hospital (Satellite Site)
-
-
Colorado
-
Aurora、Colorado、美国、80012
- 招聘中
- Rocky Mountain Cancer Centers,LLP
-
Denver、Colorado、美国、80218
- 招聘中
- Rocky Mountain Cancer Centers,LLP
-
Lone Tree、Colorado、美国、80124
- 招聘中
- Rocky Mountain Cancer Centers,LLP
-
-
Florida
-
Coral Springs、Florida、美国、33065
- 招聘中
- BRCR Medical Center Inc.
-
Land O' Lakes、Florida、美国、34638
- 尚未招聘
- Moffitt Cancer Center- Speros
-
Orange City、Florida、美国、32763
- 招聘中
- Mid Florida Hematology and Oncology Center
-
Orlando、Florida、美国、32806
- 招聘中
- Orlando Health Cancer Institute
-
Orlando、Florida、美国、32806
- 招聘中
- Orlando Health Orlando Regional Medical Center
-
Orlando、Florida、美国、32806
- 招聘中
- Orlando Health Ambulatory Care Center
-
Ruskin、Florida、美国、33570
- 尚未招聘
- Moffitt Cancer Center - SouthShore
-
Tamarac、Florida、美国、33321
- 招聘中
- BRCR Global - Tamarac
-
Tampa、Florida、美国、33612
- 尚未招聘
- Moffitt Cancer Center
-
Tampa、Florida、美国、33607
- 尚未招聘
- Moffitt Cancer Center - International Plaza
-
Tampa、Florida、美国、33612
- 尚未招聘
- Moffitt Cancer Center - McKinley Campus
-
Tampa、Florida、美国、33612
- 尚未招聘
- Moffitt McKinley Hospital
-
Wesley Chapel、Florida、美国、33544
- 尚未招聘
- Moffitt Cancer Center - Wesley Chapel
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- 招聘中
- Hackensack University Medical Center
-
Hackensack、New Jersey、美国、07601
- 招聘中
- John Theurer Cancer Center at Hackensack University Medical Center
-
Hackensack、New Jersey、美国、07601
- 招聘中
- Newman Street Imaging
-
Neptune City、New Jersey、美国、07753
- 招聘中
- John Theurer Cancer Center at JSUMC
-
New Brunswick、New Jersey、美国、08901
- 尚未招聘
- Robert Wood Johnson University Hospital
-
New Brunswick、New Jersey、美国、08901
- 尚未招聘
- Rutgers Cancer Institute
-
New Brunswick、New Jersey、美国、08901
- 尚未招聘
- Jack & Sheryl Morris Cancer Center
-
New Brunswick、New Jersey、美国、08901
- 尚未招聘
- Robert Wood Johnson University Hospital (RWJBH)
-
Paramus、New Jersey、美国、07652
- 招聘中
- John Theurer Cancer Center at From Road
-
Teaneck、New Jersey、美国、07666
- 招聘中
- Heart Center Glenpointe
-
-
New York
-
The Bronx、New York、美国、10461
- 招聘中
- Montefiore Medical Center- Montefiore Medical Park
-
-
Oregon
-
Eugene、Oregon、美国、97401
- 招聘中
- Oncology Associates of Oregon, P.C.
-
-
Texas
-
Garland、Texas、美国、75042
- 招聘中
- Dallas Cancer Specialists
-
Houston、Texas、美国、77030
- 招聘中
- Southwest Oncology Associates
-
Houston、Texas、美国、77090
- 招聘中
- Lumi Research
-
Irving、Texas、美国、75063
- 招聘中
- US Oncology Investigational Products Center (IPC)
-
Sugar Land、Texas、美国、77479
- 招聘中
- Voyage Clinical
-
-
Virginia
-
Richmond、Virginia、美国、23298
- 招聘中
- Virginia Commonwealth University
-
Richmond、Virginia、美国、23219
- 招聘中
- Virginia Commonwealth University
-
Richmond、Virginia、美国、23219
- 招聘中
- VCU Medical Center Gateway Building
-
Richmond、Virginia、美国、23235
- 招聘中
- VCU Health Stony Point
-
Richmond、Virginia、美国、23298
- 招聘中
- Massey Cancer Center Clinical & Translational Research Lab
-
South Hill、Virginia、美国、23970
- 招聘中
- VCU Health Community Memorial Hospital
-
Tappahannock、Virginia、美国、22560
- 招聘中
- VCU Health Tappahannock Hospital
-
-
-
-
-
Cadiz、西班牙、11009
- 招聘中
- Hospital Universitario Puerta del Mar
-
Granada、西班牙、18016
- 招聘中
- Hospital Universitario San Cecilio
-
Jaén、西班牙、23007
- 招聘中
- Hospital Universitario de Jaen
-
Madrid、西班牙、28040
- 招聘中
- Hospital Clinico San Carlos
-
Málaga、西班牙、29006
- 招聘中
- Cadpet Malaga
-
Seville、西班牙、41009
- 招聘中
- Hospital Universitario Virgen Macarena
-
Seville、西班牙、41009
- 招聘中
- VIVO Capuchinos
-
-
Andalusia
-
Jaén、Andalusia、西班牙、23007
- 招聘中
- HT Médica Jaen LAs Nieves
-
-
Barcelona [barcelona]
-
Barcelona、Barcelona [barcelona]、西班牙、08035
- 招聘中
- Hospital Universitari Vall d'Hebron
-
-
Catalunya [cataluña]
-
Barcelona、Catalunya [cataluña]、西班牙、08041
- 招聘中
- Hospital de la Santa Creu i Sant Pau
-
-
Cádiz
-
Jerez de la Frontera、Cádiz、西班牙、11407
- 招聘中
- Hospital Jerez de la Frontera
-
-
Madrid, Comunidad de
-
Madrid、Madrid, Comunidad de、西班牙、28041
- 招聘中
- Hospital Universitario 12 de Octubre
-
Madrid、Madrid, Comunidad de、西班牙、280006
- 招聘中
- Hospital Nuestra Señora del Rosario
-
-
Málaga
-
Málaga、Málaga、西班牙、29010
- 招聘中
- Hospital Universitario Virgen de la Victoria
-
Málaga、Málaga、西班牙、29016
- 招聘中
- Clínica Radiólogica Mario Gallegos
-
-
Valenciana, Comunitat
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Valencia、Valenciana, Comunitat、西班牙、46009
- 尚未招聘
- Fundación Instituto Valenciano de Oncología
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
- PD-L1 status available
- Part B only: PD-L1 ≥ TPS 1%
- Measurable disease based on RECIST v1.1 per investigator.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function
Exclusion Criteria:
- Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
- History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- Leptomeningeal disease
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC
- Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy >30 Gy to the lung within 6 months of first dose of study intervention
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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 |
|---|---|
|
实验性的：PF-08634404 + PF-08046054/SGN-PDL1V (Part B)
Participants will receive PF-08634404 in combination with other anticancer agents as per protocol. |
-Concentrate for solution for infusion
其他名称：
-Powder for concentrate for solution for infusion. Single use vial. |
|
实验性的：PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
-Concentrate for solution for infusion
其他名称：
-Powder for concentrate for solution for infusion. Single use vial
其他名称：
|
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 |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Through 90 days after the last study intervention; Up to approximately 5 years
|
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. |
Through 90 days after the last study intervention; Up to approximately 5 years
|
|
Phase I: Number of participants with dose limiting toxicity (DLT)
大体时间：Through 90 days after the last study intervention; Up to approximately 5 years
|
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period. |
Through 90 days after the last study intervention; Up to approximately 5 years
|
|
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator
大体时间：Up to approximately 5 Years
|
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1. |
Up to approximately 5 Years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
出现临床实验室异常的受试者人数
大体时间：从末次研究干预后90天内；最长约5年
|
从末次研究干预后90天内；最长约5年
|
|
|
Phase I: Confirmed ORR per RECIST v1.1 by investigator
大体时间：Up to approximately 5 Years
|
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1. |
Up to approximately 5 Years
|
|
Disease Control Rate (DCR) per RECIST v1.1 by investigator
大体时间：Up to approximately 5 years
|
DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1. |
Up to approximately 5 years
|
|
Duration of Response (DOR) per RECIST v1.1 by investigator
大体时间：Up to approximately 5 years
|
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
Up to approximately 5 years
|
|
Progression Free Survival (PFS) per RECIST v1.1 by investigator
大体时间：Up to approximately 5 years
|
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first. |
Up to approximately 5 years
|
|
Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents
大体时间：Up to 37 days after the last dose of treatment
|
To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents. |
Up to 37 days after the last dose of treatment
|
|
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents
大体时间：Up to 37 days after the last dose of treatment
|
To characterize the immunogenicity of PF-08634404 with anticancer agents. |
Up to 37 days after the last dose of treatment
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：Up to approximately 5 years
|
Overall survival defined as the time from the date of randomization to the date of death due to any cause. |
Up to approximately 5 years
|
合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- C6461020
- 2025-523526-40-00 (克蒂斯)
- Symbiotic-Lung-20 (其他标识符：Pfizer)
- 2025 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.