진행성 암에서 다양한 항암제와 병용 투여되는 PF-08634404 연구 약물에 관한 연구
PF-08634404와 다양한 항암제 병용 요법의 안전성, 약동학 및 예비 효능을 평가하기 위한 중재적 개방형 1B/2상 임상시험: 진행성 고형암 환자 대상
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
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Kaohsiung City, 대만, 807
- 모병
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, 대만, 83301
- 모병
- Chang Gung Memorial Hospital at Kaohsiung
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Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital
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Taipei, 대만, 10449
- 모병
- Mackay Memorial Hospital
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Taipei, 대만, 11217
- 모병
- Taipei Veterans General Hospital
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, 독일, 79106
- 모병
- Universitaetsklinikum Freiburg
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Hesse
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Frankfurt am Main, Hesse, 독일, 60488
- 모병
- Krankenhaus Nordwest GmbH
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, 독일, 40479
- 모병
- Marien Hospital Düsseldorf
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- 모병
- Highlands Oncology Group, PA
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Rogers, Arkansas, 미국, 72758
- 모병
- Highlands Oncology Group, PA
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Springdale, Arkansas, 미국, 72762
- 모병
- Highlands Oncology Group, PA
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California
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Fullerton, California, 미국, 92835
- 모병
- Providence Medical Foundation
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Fullerton, California, 미국, 92835
- 모병
- Providence St. Jude Medical Center
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Fullerton, California, 미국, 92835
- 모병
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
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La Jolla, California, 미국, 92037
- 모병
- Scripps Green Hospital
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La Jolla, California, 미국, 92037
- 모병
- Scripps Clinic Torrey Pines (Scripps Cancer Center)
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La Jolla, California, 미국, 92037
- 모병
- Scripps Shiley Pavilion
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Los Angeles, California, 미국, 90067
- 모병
- Valkyrie Clinical Trials
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Los Angeles, California, 미국, 90025
- 모병
- START Los Angeles, LLC
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Los Angeles, California, 미국, 90067
- 모병
- Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)
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Los Angeles, California, 미국, 90067
- 모병
- LACN Century City
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Los Angeles, California, 미국, 90067
- 모병
- Valkyrie Clinical Trials (Additional Site Suite)
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Panorama City, California, 미국, 91402
- 모병
- Mission Community Hospital (Satellite Site)
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Colorado
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Aurora, Colorado, 미국, 80012
- 모병
- Rocky Mountain Cancer Centers,LLP
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Denver, Colorado, 미국, 80218
- 모병
- Rocky Mountain Cancer Centers,LLP
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Lone Tree, Colorado, 미국, 80124
- 모병
- Rocky Mountain Cancer Centers,LLP
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Florida
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Coral Springs, Florida, 미국, 33065
- 모병
- BRCR Medical Center Inc.
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Land O' Lakes, Florida, 미국, 34638
- 아직 모집하지 않음
- Moffitt Cancer Center- Speros
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Orange City, Florida, 미국, 32763
- 모병
- Mid Florida Hematology and Oncology Center
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health Cancer Institute
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health Orlando Regional Medical Center
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health Ambulatory Care Center
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Ruskin, Florida, 미국, 33570
- 아직 모집하지 않음
- Moffitt Cancer Center - SouthShore
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Tamarac, Florida, 미국, 33321
- 모병
- BRCR Global - Tamarac
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Tampa, Florida, 미국, 33612
- 아직 모집하지 않음
- Moffitt Cancer Center
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Tampa, Florida, 미국, 33607
- 아직 모집하지 않음
- Moffitt Cancer Center - International Plaza
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Tampa, Florida, 미국, 33612
- 아직 모집하지 않음
- Moffitt Cancer Center - McKinley Campus
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Tampa, Florida, 미국, 33612
- 아직 모집하지 않음
- Moffitt McKinley Hospital
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Wesley Chapel, Florida, 미국, 33544
- 아직 모집하지 않음
- Moffitt Cancer Center - Wesley Chapel
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- 모병
- Hackensack University Medical Center
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Hackensack, New Jersey, 미국, 07601
- 모병
- John Theurer Cancer Center at Hackensack University Medical Center
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Hackensack, New Jersey, 미국, 07601
- 모병
- Newman Street Imaging
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Neptune City, New Jersey, 미국, 07753
- 모병
- John Theurer Cancer Center at JSUMC
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New Brunswick, New Jersey, 미국, 08901
- 아직 모집하지 않음
- Robert Wood Johnson University Hospital
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New Brunswick, New Jersey, 미국, 08901
- 아직 모집하지 않음
- Rutgers Cancer Institute
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New Brunswick, New Jersey, 미국, 08901
- 아직 모집하지 않음
- Jack & Sheryl Morris Cancer Center
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New Brunswick, New Jersey, 미국, 08901
- 아직 모집하지 않음
- Robert Wood Johnson University Hospital (RWJBH)
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Paramus, New Jersey, 미국, 07652
- 모병
- John Theurer Cancer Center at From Road
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Teaneck, New Jersey, 미국, 07666
- 모병
- Heart Center Glenpointe
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New York
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The Bronx, New York, 미국, 10461
- 모병
- Montefiore Medical Center- Montefiore Medical Park
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Oregon
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Eugene, Oregon, 미국, 97401
- 모병
- Oncology Associates of Oregon, P.C.
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Texas
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Garland, Texas, 미국, 75042
- 모병
- Dallas Cancer Specialists
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Houston, Texas, 미국, 77030
- 모병
- Southwest Oncology Associates
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Houston, Texas, 미국, 77090
- 모병
- Lumi Research
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Irving, Texas, 미국, 75063
- 모병
- US Oncology Investigational Products Center (IPC)
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Sugar Land, Texas, 미국, 77479
- 모병
- Voyage Clinical
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Virginia
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Richmond, Virginia, 미국, 23298
- 모병
- Virginia Commonwealth University
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Richmond, Virginia, 미국, 23219
- 모병
- Virginia Commonwealth University
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Richmond, Virginia, 미국, 23219
- 모병
- VCU Medical Center Gateway Building
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Richmond, Virginia, 미국, 23235
- 모병
- VCU Health Stony Point
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Richmond, Virginia, 미국, 23298
- 모병
- Massey Cancer Center Clinical & Translational Research Lab
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South Hill, Virginia, 미국, 23970
- 모병
- VCU Health Community Memorial Hospital
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Tappahannock, Virginia, 미국, 22560
- 모병
- VCU Health Tappahannock Hospital
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Cadiz, 스페인, 11009
- 모병
- Hospital Universitario Puerta del Mar
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Granada, 스페인, 18016
- 모병
- Hospital Universitario San Cecilio
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Jaén, 스페인, 23007
- 모병
- Hospital Universitario de Jaen
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Madrid, 스페인, 28040
- 모병
- Hospital Clinico San Carlos
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Málaga, 스페인, 29006
- 모병
- Cadpet Malaga
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Seville, 스페인, 41009
- 모병
- Hospital Universitario Virgen Macarena
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Seville, 스페인, 41009
- 모병
- VIVO Capuchinos
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Andalusia
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Jaén, Andalusia, 스페인, 23007
- 모병
- HT Médica Jaen LAs Nieves
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Barcelona [barcelona]
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Barcelona, Barcelona [barcelona], 스페인, 08035
- 모병
- Hospital Universitari Vall d'Hebron
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], 스페인, 08041
- 모병
- Hospital de la Santa Creu i Sant Pau
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Cádiz
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Jerez de la Frontera, Cádiz, 스페인, 11407
- 모병
- Hospital Jerez de la Frontera
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, 스페인, 28041
- 모병
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Comunidad de, 스페인, 280006
- 모병
- Hospital Nuestra Señora del Rosario
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Málaga
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Málaga, Málaga, 스페인, 29010
- 모병
- Hospital Universitario Virgen de la Victoria
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Málaga, Málaga, 스페인, 29016
- 모병
- Clínica Radiólogica Mario Gallegos
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, 스페인, 46009
- 아직 모집하지 않음
- Fundación Instituto Valenciano de Oncología
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Pesaro AND Urbino
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Fano, Pesaro AND Urbino, 이탈리아, 61032
- 아직 모집하지 않음
- Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
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ROME
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Roma, ROME, 이탈리아, 00144
- 아직 모집하지 않음
- IRCCS Istituto Nazionale dei Tumori Regina Elena
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Roma, ROME, 이탈리아, 00186
- 아직 모집하지 않음
- Ospedale Isola Tiberina - Gemelli Isola
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Chiba
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Kashiwa, Chiba, 일본, 277-8577
- 모병
- National Cancer Center Hospital East
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Miyagi
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Sendai, Miyagi, 일본, 9810914
- 아직 모집하지 않음
- Sendai Kousei Hospital
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Osaka
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Hirakata, Osaka, 일본, 573-1191
- 모병
- Kansai Medical University Hospital
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Shizuoka
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Nagaizumi-cho, Shizuoka, 일본, 411-8777
- 모병
- Shizuoka Cancer Center
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Tokyo
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Bunkyo-ku, Tokyo, 일본, 113-8677
- 모병
- Tokyo Metropolitan Komagome Hospital
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Bunkyo-ku, Tokyo, 일본, 113-8603
- 아직 모집하지 않음
- Nippon Medical School Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100730
- 모병
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, 중국, 100142
- 모병
- Beijing Cancer hospital
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Fujian
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Fuzhou, Fujian, 중국, 350014
- 모병
- Fujian Cancer Hospital
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Hubei
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Wuhan, Hubei, 중국, 430030
- 모병
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, 중국, 210029
- 아직 모집하지 않음
- Jiangsu Province Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- 아직 모집하지 않음
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, 중국, 200030
- 모병
- Shanghai Chest Hospital
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Zhejiang
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Taizhou, Zhejiang, 중국, 317000
- 모병
- Taizhou Hospital of Zhejiang Province
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Mayagüez, 푸에르토 리코, 00680
- 모병
- Pan American Center for Oncology Trials, LLC - Mayaguez
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Rio Piedras, 푸에르토 리코, 00935
- 모병
- Pan American Center for Oncology Trials, LLC
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San Juan, 푸에르토 리코, 00917
- 모병
- BRCR Global Puerto Rico - Hato Rey
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-
-
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Aquitaine
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Bordeaux, Aquitaine, 프랑스, 33076
- 모병
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
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CÔTE D'OR
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Dijon, CÔTE D'OR, 프랑스, 21079
- 모병
- Centre Georges François Leclerc
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, 프랑스, 13273
- 모병
- Institut Paoli-Calmettes
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Île-de-France Region
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Paris, Île-de-France Region, 프랑스, 75014
- 모병
- Groupe hospitalier Paris saint Joseph
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
-Powder for concentrate for solution for infusion. Single use vial. |
|
실험적: PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
-Concentrate for solution for infusion
다른 이름들:
-Powder for concentrate for solution for infusion. Single use vial
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
임상 검사 이상이 있는 참가자 수
기간: 연구 개입 종료 후 90일까지; 최대 약 5년
|
연구 개입 종료 후 90일까지; 최대 약 5년
|
|
|
Phase I: Confirmed ORR per RECIST v1.1 by investigator
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- C6461020
- 2025-523526-40-00 (씨티스)
- Symbiotic-Lung-20 (기타 식별자: Pfizer)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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