- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07227298
Een studie om te leren over het studiegeneesmiddel genaamd PF-08634404 in combinatie met verschillende antikankermiddelen bij gevorderde kankers
EEN INTERVENTIONELE OPEN-LABEL FASE 1B/2-STUDIE OM DE VEILIGHEID, FARMACOKINETIEK EN VOORLOPIGE EFFECTIVITEIT VAN PF-08634404 IN COMBINATIE MET VERSCHILLEND ANTIKANKERMIDDELEN TE EVALUEREN BIJ DEELNEMERS MET GEVORDERDE SOLIDE TUMOREN
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Werving
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, China, 100142
- Werving
- Beijing Cancer hospital
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Fujian
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Fuzhou, Fujian, China, 350014
- Werving
- Fujian Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430030
- Werving
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Nog niet aan het werven
- Jiangsu Province Hospital
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Nog niet aan het werven
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, China, 200030
- Werving
- Shanghai Chest Hospital
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Zhejiang
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Taizhou, Zhejiang, China, 317000
- Werving
- Taizhou Hospital of Zhejiang Province
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Duitsland, 79106
- Werving
- Universitaetsklinikum Freiburg
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Hesse
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Frankfurt am Main, Hesse, Duitsland, 60488
- Werving
- Krankenhaus Nordwest GmbH
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Duitsland, 40479
- Werving
- Marien Hospital Düsseldorf
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-
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Aquitaine
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Bordeaux, Aquitaine, Frankrijk, 33076
- Werving
- 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, Frankrijk, 21079
- Werving
- 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, Frankrijk, 13273
- Werving
- Institut Paoli-Calmettes
-
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Île-de-France Region
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Paris, Île-de-France Region, Frankrijk, 75014
- Werving
- Groupe hospitalier Paris saint Joseph
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Pesaro AND Urbino
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Fano, Pesaro AND Urbino, Italië, 61032
- Nog niet aan het werven
- Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
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ROME
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Roma, ROME, Italië, 00144
- Nog niet aan het werven
- IRCCS Istituto Nazionale dei Tumori Regina Elena
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Roma, ROME, Italië, 00186
- Nog niet aan het werven
- Ospedale Isola Tiberina - Gemelli Isola
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Werving
- National Cancer Center Hospital East
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Miyagi
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Sendai, Miyagi, Japan, 9810914
- Nog niet aan het werven
- Sendai Kousei Hospital
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Werving
- Kansai Medical University Hospital
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Shizuoka
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Nagaizumi-cho, Shizuoka, Japan, 411-8777
- Werving
- Shizuoka Cancer Center
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8677
- Werving
- Tokyo Metropolitan Komagome Hospital
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Bunkyo-ku, Tokyo, Japan, 113-8603
- Nog niet aan het werven
- Nippon Medical School Hospital
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-
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Mayagüez, Puerto Rico, 00680
- Werving
- Pan American Center for Oncology Trials, LLC - Mayaguez
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Rio Piedras, Puerto Rico, 00935
- Werving
- Pan American Center for Oncology Trials, LLC
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San Juan, Puerto Rico, 00917
- Werving
- BRCR Global Puerto Rico - Hato Rey
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-
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Cadiz, Spanje, 11009
- Werving
- Hospital Universitario Puerta del Mar
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Granada, Spanje, 18016
- Werving
- Hospital Universitario San Cecilio
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Jaén, Spanje, 23007
- Werving
- Hospital Universitario de Jaen
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Madrid, Spanje, 28040
- Werving
- Hospital Clinico San Carlos
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Málaga, Spanje, 29006
- Werving
- Cadpet Malaga
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Seville, Spanje, 41009
- Werving
- Hospital Universitario Virgen Macarena
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Seville, Spanje, 41009
- Werving
- VIVO Capuchinos
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Andalusia
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Jaén, Andalusia, Spanje, 23007
- Werving
- HT Médica Jaen LAs Nieves
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Barcelona [barcelona]
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Barcelona, Barcelona [barcelona], Spanje, 08035
- Werving
- Hospital Universitari Vall d'Hebron
-
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], Spanje, 08041
- Werving
- Hospital de la Santa Creu i Sant Pau
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Cádiz
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Jerez de la Frontera, Cádiz, Spanje, 11407
- Werving
- Hospital Jerez de la Frontera
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanje, 28041
- Werving
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Comunidad de, Spanje, 280006
- Werving
- Hospital Nuestra Señora del Rosario
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Málaga
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Málaga, Málaga, Spanje, 29010
- Werving
- Hospital Universitario Virgen de la Victoria
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Málaga, Málaga, Spanje, 29016
- Werving
- Clínica Radiólogica Mario Gallegos
-
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spanje, 46009
- Nog niet aan het werven
- Fundación Instituto Valenciano de Oncología
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Kaohsiung City, Taiwan, 807
- Werving
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, Taiwan, 83301
- Werving
- Chang Gung Memorial Hospital at Kaohsiung
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Tainan, Taiwan, 704
- Werving
- National Cheng Kung University Hospital
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Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital
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Taipei, Taiwan, 10449
- Werving
- Mackay Memorial Hospital
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Taipei, Taiwan, 11217
- Werving
- Taipei Veterans General Hospital
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
- Werving
- Highlands Oncology Group, PA
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Rogers, Arkansas, Verenigde Staten, 72758
- Werving
- Highlands Oncology Group, PA
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Springdale, Arkansas, Verenigde Staten, 72762
- Werving
- Highlands Oncology Group, PA
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California
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Fullerton, California, Verenigde Staten, 92835
- Werving
- Providence Medical Foundation
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Fullerton, California, Verenigde Staten, 92835
- Werving
- Providence St. Jude Medical Center
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Fullerton, California, Verenigde Staten, 92835
- Werving
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
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La Jolla, California, Verenigde Staten, 92037
- Werving
- Scripps Green Hospital
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La Jolla, California, Verenigde Staten, 92037
- Werving
- Scripps Clinic Torrey Pines (Scripps Cancer Center)
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La Jolla, California, Verenigde Staten, 92037
- Werving
- Scripps Shiley Pavilion
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Los Angeles, California, Verenigde Staten, 90067
- Werving
- Valkyrie Clinical Trials
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Los Angeles, California, Verenigde Staten, 90025
- Werving
- START Los Angeles, LLC
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Los Angeles, California, Verenigde Staten, 90067
- Werving
- Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)
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Los Angeles, California, Verenigde Staten, 90067
- Werving
- LACN Century City
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Los Angeles, California, Verenigde Staten, 90067
- Werving
- Valkyrie Clinical Trials (Additional Site Suite)
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Panorama City, California, Verenigde Staten, 91402
- Werving
- Mission Community Hospital (Satellite Site)
-
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Colorado
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Aurora, Colorado, Verenigde Staten, 80012
- Werving
- Rocky Mountain Cancer Centers,LLP
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Denver, Colorado, Verenigde Staten, 80218
- Werving
- Rocky Mountain Cancer Centers,LLP
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Lone Tree, Colorado, Verenigde Staten, 80124
- Werving
- Rocky Mountain Cancer Centers,LLP
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Florida
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Coral Springs, Florida, Verenigde Staten, 33065
- Werving
- BRCR Medical Center Inc.
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Land O' Lakes, Florida, Verenigde Staten, 34638
- Nog niet aan het werven
- Moffitt Cancer Center- Speros
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Orange City, Florida, Verenigde Staten, 32763
- Werving
- Mid Florida Hematology and Oncology Center
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Orlando, Florida, Verenigde Staten, 32806
- Werving
- Orlando Health Cancer Institute
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Orlando, Florida, Verenigde Staten, 32806
- Werving
- Orlando Health Orlando Regional Medical Center
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Orlando, Florida, Verenigde Staten, 32806
- Werving
- Orlando Health Ambulatory Care Center
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Ruskin, Florida, Verenigde Staten, 33570
- Nog niet aan het werven
- Moffitt Cancer Center - SouthShore
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Tamarac, Florida, Verenigde Staten, 33321
- Werving
- BRCR Global - Tamarac
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Tampa, Florida, Verenigde Staten, 33612
- Nog niet aan het werven
- Moffitt Cancer Center
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Tampa, Florida, Verenigde Staten, 33607
- Nog niet aan het werven
- Moffitt Cancer Center - International Plaza
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Tampa, Florida, Verenigde Staten, 33612
- Nog niet aan het werven
- Moffitt Cancer Center - McKinley Campus
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Tampa, Florida, Verenigde Staten, 33612
- Nog niet aan het werven
- Moffitt McKinley Hospital
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Wesley Chapel, Florida, Verenigde Staten, 33544
- Nog niet aan het werven
- Moffitt Cancer Center - Wesley Chapel
-
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- Hackensack University Medical Center
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- John Theurer Cancer Center at Hackensack University Medical Center
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- Newman Street Imaging
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Neptune City, New Jersey, Verenigde Staten, 07753
- Werving
- John Theurer Cancer Center at JSUMC
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New Brunswick, New Jersey, Verenigde Staten, 08901
- Nog niet aan het werven
- Robert Wood Johnson University Hospital
-
New Brunswick, New Jersey, Verenigde Staten, 08901
- Nog niet aan het werven
- Rutgers Cancer Institute
-
New Brunswick, New Jersey, Verenigde Staten, 08901
- Nog niet aan het werven
- Jack & Sheryl Morris Cancer Center
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New Brunswick, New Jersey, Verenigde Staten, 08901
- Nog niet aan het werven
- Robert Wood Johnson University Hospital (RWJBH)
-
Paramus, New Jersey, Verenigde Staten, 07652
- Werving
- John Theurer Cancer Center at From Road
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Teaneck, New Jersey, Verenigde Staten, 07666
- Werving
- Heart Center Glenpointe
-
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New York
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The Bronx, New York, Verenigde Staten, 10461
- Werving
- Montefiore Medical Center- Montefiore Medical Park
-
-
Oregon
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Eugene, Oregon, Verenigde Staten, 97401
- Werving
- Oncology Associates of Oregon, P.C.
-
-
Texas
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Garland, Texas, Verenigde Staten, 75042
- Werving
- Dallas Cancer Specialists
-
Houston, Texas, Verenigde Staten, 77030
- Werving
- Southwest Oncology Associates
-
Houston, Texas, Verenigde Staten, 77090
- Werving
- Lumi Research
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Irving, Texas, Verenigde Staten, 75063
- Werving
- US Oncology Investigational Products Center (IPC)
-
Sugar Land, Texas, Verenigde Staten, 77479
- Werving
- Voyage Clinical
-
-
Virginia
-
Richmond, Virginia, Verenigde Staten, 23298
- Werving
- Virginia Commonwealth University
-
Richmond, Virginia, Verenigde Staten, 23219
- Werving
- Virginia Commonwealth University
-
Richmond, Virginia, Verenigde Staten, 23219
- Werving
- VCU Medical Center Gateway Building
-
Richmond, Virginia, Verenigde Staten, 23235
- Werving
- VCU Health Stony Point
-
Richmond, Virginia, Verenigde Staten, 23298
- Werving
- Massey Cancer Center Clinical & Translational Research Lab
-
South Hill, Virginia, Verenigde Staten, 23970
- Werving
- VCU Health Community Memorial Hospital
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Tappahannock, Virginia, Verenigde Staten, 22560
- Werving
- VCU Health Tappahannock Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
-Powder for concentrate for solution for infusion. Single use vial. |
|
Experimenteel: PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
-Concentrate for solution for infusion
Andere namen:
-Powder for concentrate for solution for infusion. Single use vial
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Aantal deelnemers met klinische laboratoriumafwijkingen
Tijdsspanne: Gedurende 90 dagen na de laatste studie-interventie; Tot maximaal ongeveer 5 jaar
|
Gedurende 90 dagen na de laatste studie-interventie; Tot maximaal ongeveer 5 jaar
|
|
|
Phase I: Confirmed ORR per RECIST v1.1 by investigator
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- C6461020
- 2025-523526-40-00 (Ctis)
- Symbiotic-Lung-20 (Andere identificatie: Pfizer)
- 2025 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .