- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07227298
En studie för att lära sig om studieläkemedlet PF-08634404 i kombination med olika antikancerläkemedel vid avancerad cancer
EN INTERVENTIONELL ÖPPEN FAS 1B/2-STUDIE FÖR ATT UTVÄRDERA SÄKERHET, FARMAKOKINETIK OCH PRELIMINÄR EFFEKT AV PF-08634404 I KOMBINATION MED OLIKA ANTICANCERMEDEL HOS DELTAGARE MED AVANCERADE SOLIDA TUMÖRER
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studieorter
-
-
Aquitaine
-
Bordeaux, Aquitaine, Frankrike, 33076
- Rekrytering
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
-
-
CÔTE D'OR
-
Dijon, CÔTE D'OR, Frankrike, 21079
- Rekrytering
- Centre Georges François Leclerc
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille, Provence-Alpes-Côte d'Azur Region, Frankrike, 13273
- Rekrytering
- Institut Paoli-Calmettes
-
-
Île-de-France Region
-
Paris, Île-de-France Region, Frankrike, 75014
- Rekrytering
- Groupe hospitalier Paris saint Joseph
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, Förenta staterna, 72703
- Rekrytering
- Highlands Oncology Group, PA
-
Rogers, Arkansas, Förenta staterna, 72758
- Rekrytering
- Highlands Oncology Group, PA
-
Springdale, Arkansas, Förenta staterna, 72762
- Rekrytering
- Highlands Oncology Group, PA
-
-
California
-
Fullerton, California, Förenta staterna, 92835
- Rekrytering
- Providence Medical Foundation
-
Fullerton, California, Förenta staterna, 92835
- Rekrytering
- Providence St. Jude Medical Center
-
Fullerton, California, Förenta staterna, 92835
- Rekrytering
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
-
La Jolla, California, Förenta staterna, 92037
- Rekrytering
- Scripps Green Hospital
-
La Jolla, California, Förenta staterna, 92037
- Rekrytering
- Scripps Clinic Torrey Pines (Scripps Cancer Center)
-
La Jolla, California, Förenta staterna, 92037
- Rekrytering
- Scripps Shiley Pavilion
-
Los Angeles, California, Förenta staterna, 90067
- Rekrytering
- Valkyrie Clinical Trials
-
Los Angeles, California, Förenta staterna, 90025
- Rekrytering
- START Los Angeles, LLC
-
Los Angeles, California, Förenta staterna, 90067
- Rekrytering
- Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)
-
Los Angeles, California, Förenta staterna, 90067
- Rekrytering
- LACN Century City
-
Los Angeles, California, Förenta staterna, 90067
- Rekrytering
- Valkyrie Clinical Trials (Additional Site Suite)
-
Panorama City, California, Förenta staterna, 91402
- Rekrytering
- Mission Community Hospital (Satellite Site)
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80012
- Rekrytering
- Rocky Mountain Cancer Centers,LLP
-
Denver, Colorado, Förenta staterna, 80218
- Rekrytering
- Rocky Mountain Cancer Centers,LLP
-
Lone Tree, Colorado, Förenta staterna, 80124
- Rekrytering
- Rocky Mountain Cancer Centers,LLP
-
-
Florida
-
Coral Springs, Florida, Förenta staterna, 33065
- Rekrytering
- BRCR Medical Center Inc.
-
Land O' Lakes, Florida, Förenta staterna, 34638
- Har inte rekryterat ännu
- Moffitt Cancer Center- Speros
-
Orange City, Florida, Förenta staterna, 32763
- Rekrytering
- Mid Florida Hematology and Oncology Center
-
Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- Orlando Health Cancer Institute
-
Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- Orlando Health Orlando Regional Medical Center
-
Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- Orlando Health Ambulatory Care Center
-
Ruskin, Florida, Förenta staterna, 33570
- Har inte rekryterat ännu
- Moffitt Cancer Center - SouthShore
-
Tamarac, Florida, Förenta staterna, 33321
- Rekrytering
- BRCR Global - Tamarac
-
Tampa, Florida, Förenta staterna, 33612
- Har inte rekryterat ännu
- Moffitt Cancer Center
-
Tampa, Florida, Förenta staterna, 33607
- Har inte rekryterat ännu
- Moffitt Cancer Center - International Plaza
-
Tampa, Florida, Förenta staterna, 33612
- Har inte rekryterat ännu
- Moffitt Cancer Center - McKinley Campus
-
Tampa, Florida, Förenta staterna, 33612
- Har inte rekryterat ännu
- Moffitt McKinley Hospital
-
Wesley Chapel, Florida, Förenta staterna, 33544
- Har inte rekryterat ännu
- Moffitt Cancer Center - Wesley Chapel
-
-
New Jersey
-
Hackensack, New Jersey, Förenta staterna, 07601
- Rekrytering
- Hackensack University Medical Center
-
Hackensack, New Jersey, Förenta staterna, 07601
- Rekrytering
- John Theurer Cancer Center at Hackensack University Medical Center
-
Hackensack, New Jersey, Förenta staterna, 07601
- Rekrytering
- Newman Street Imaging
-
Neptune City, New Jersey, Förenta staterna, 07753
- Rekrytering
- John Theurer Cancer Center at JSUMC
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Har inte rekryterat ännu
- Robert Wood Johnson University Hospital
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Har inte rekryterat ännu
- Rutgers Cancer Institute
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Har inte rekryterat ännu
- Jack & Sheryl Morris Cancer Center
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Har inte rekryterat ännu
- Robert Wood Johnson University Hospital (RWJBH)
-
Paramus, New Jersey, Förenta staterna, 07652
- Rekrytering
- John Theurer Cancer Center at From Road
-
Teaneck, New Jersey, Förenta staterna, 07666
- Rekrytering
- Heart Center Glenpointe
-
-
New York
-
The Bronx, New York, Förenta staterna, 10461
- Rekrytering
- Montefiore Medical Center- Montefiore Medical Park
-
-
Oregon
-
Eugene, Oregon, Förenta staterna, 97401
- Rekrytering
- Oncology Associates of Oregon, P.C.
-
-
Texas
-
Garland, Texas, Förenta staterna, 75042
- Rekrytering
- Dallas Cancer Specialists
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Southwest Oncology Associates
-
Houston, Texas, Förenta staterna, 77090
- Rekrytering
- Lumi Research
-
Irving, Texas, Förenta staterna, 75063
- Rekrytering
- US Oncology Investigational Products Center (IPC)
-
Sugar Land, Texas, Förenta staterna, 77479
- Rekrytering
- Voyage Clinical
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Rekrytering
- Virginia Commonwealth University
-
Richmond, Virginia, Förenta staterna, 23219
- Rekrytering
- Virginia Commonwealth University
-
Richmond, Virginia, Förenta staterna, 23219
- Rekrytering
- VCU Medical Center Gateway Building
-
Richmond, Virginia, Förenta staterna, 23235
- Rekrytering
- VCU Health Stony Point
-
Richmond, Virginia, Förenta staterna, 23298
- Rekrytering
- Massey Cancer Center Clinical & Translational Research Lab
-
South Hill, Virginia, Förenta staterna, 23970
- Rekrytering
- VCU Health Community Memorial Hospital
-
Tappahannock, Virginia, Förenta staterna, 22560
- Rekrytering
- VCU Health Tappahannock Hospital
-
-
-
-
Pesaro AND Urbino
-
Fano, Pesaro AND Urbino, Italien, 61032
- Har inte rekryterat ännu
- Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
-
-
ROME
-
Roma, ROME, Italien, 00144
- Har inte rekryterat ännu
- IRCCS Istituto Nazionale dei Tumori Regina Elena
-
Roma, ROME, Italien, 00186
- Har inte rekryterat ännu
- Ospedale Isola Tiberina - Gemelli Isola
-
-
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- Rekrytering
- National Cancer Center Hospital East
-
-
Miyagi
-
Sendai, Miyagi, Japan, 9810914
- Har inte rekryterat ännu
- Sendai Kousei Hospital
-
-
Osaka
-
Hirakata, Osaka, Japan, 573-1191
- Rekrytering
- Kansai Medical University Hospital
-
-
Shizuoka
-
Nagaizumi-cho, Shizuoka, Japan, 411-8777
- Rekrytering
- Shizuoka Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8677
- Rekrytering
- Tokyo Metropolitan Komagome Hospital
-
Bunkyo-ku, Tokyo, Japan, 113-8603
- Har inte rekryterat ännu
- Nippon Medical School Hospital
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Rekrytering
- Peking Union Medical College Hospital
-
Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer hospital
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Rekrytering
- Fujian Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Rekrytering
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Har inte rekryterat ännu
- Jiangsu Province Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Har inte rekryterat ännu
- Fudan University Shanghai Cancer Center
-
Shanghai, Shanghai Municipality, Kina, 200030
- Rekrytering
- Shanghai Chest Hospital
-
-
Zhejiang
-
Taizhou, Zhejiang, Kina, 317000
- Rekrytering
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Mayagüez, Puerto Rico, 00680
- Rekrytering
- Pan American Center for Oncology Trials, LLC - Mayaguez
-
Rio Piedras, Puerto Rico, 00935
- Rekrytering
- Pan American Center for Oncology Trials, LLC
-
San Juan, Puerto Rico, 00917
- Rekrytering
- BRCR Global Puerto Rico - Hato Rey
-
-
-
-
-
Cadiz, Spanien, 11009
- Rekrytering
- Hospital Universitario Puerta del Mar
-
Granada, Spanien, 18016
- Rekrytering
- Hospital Universitario San Cecilio
-
Jaén, Spanien, 23007
- Rekrytering
- Hospital Universitario de Jaen
-
Madrid, Spanien, 28040
- Rekrytering
- Hospital Clinico San Carlos
-
Málaga, Spanien, 29006
- Rekrytering
- Cadpet Malaga
-
Seville, Spanien, 41009
- Rekrytering
- Hospital Universitario Virgen Macarena
-
Seville, Spanien, 41009
- Rekrytering
- VIVO Capuchinos
-
-
Andalusia
-
Jaén, Andalusia, Spanien, 23007
- Rekrytering
- HT Médica Jaen LAs Nieves
-
-
Barcelona [barcelona]
-
Barcelona, Barcelona [barcelona], Spanien, 08035
- Rekrytering
- Hospital Universitari Vall d'Hebron
-
-
Catalunya [cataluña]
-
Barcelona, Catalunya [cataluña], Spanien, 08041
- Rekrytering
- Hospital de la Santa Creu i Sant Pau
-
-
Cádiz
-
Jerez de la Frontera, Cádiz, Spanien, 11407
- Rekrytering
- Hospital Jerez de la Frontera
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre
-
Madrid, Madrid, Comunidad de, Spanien, 280006
- Rekrytering
- Hospital Nuestra Señora del Rosario
-
-
Málaga
-
Málaga, Málaga, Spanien, 29010
- Rekrytering
- Hospital Universitario Virgen de la Victoria
-
Málaga, Málaga, Spanien, 29016
- Rekrytering
- Clínica Radiólogica Mario Gallegos
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spanien, 46009
- Har inte rekryterat ännu
- Fundación Instituto Valenciano de Oncología
-
-
-
-
-
Kaohsiung City, Taiwan, 807
- Rekrytering
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City, Taiwan, 83301
- Rekrytering
- Chang Gung Memorial Hospital at Kaohsiung
-
Tainan, Taiwan, 704
- Rekrytering
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
-
Taipei, Taiwan, 10449
- Rekrytering
- Mackay Memorial Hospital
-
Taipei, Taiwan, 11217
- Rekrytering
- Taipei Veterans General Hospital
-
-
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Rekrytering
- Universitaetsklinikum Freiburg
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60488
- Rekrytering
- Krankenhaus Nordwest GmbH
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40479
- Rekrytering
- Marien Hospital Düsseldorf
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
-Powder for concentrate for solution for infusion. Single use vial. |
|
Experimentell: PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
-Concentrate for solution for infusion
Andra namn:
-Powder for concentrate for solution for infusion. Single use vial
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Antal deltagare med kliniska laboratorieförändringar
Tidsram: Under 90 dagar efter den sista studieinterventionen; Upp till cirka 5 år
|
Under 90 dagar efter den sista studieinterventionen; Upp till cirka 5 år
|
|
|
Phase I: Confirmed ORR per RECIST v1.1 by investigator
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C6461020
- 2025-523526-40-00 (Ctis)
- Symbiotic-Lung-20 (Annan identifierare: Pfizer)
- 2025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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