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Recruiting Phase 1/2 NCT07227298

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Phase 1/2 – combined early trial
Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer Carcinoma, Non-Small Cell Lung Non-Small Cell Lung Cancer

Sponsor: Pfizer

trial.available_in: БГ
Overview
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 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 of the study will look at how well the new medicine PF-08634404 works when used together with another medicine. 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.
Who can participate
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 * History of another malignancy within 3 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, unresectable, or metastatic NSCLC * Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
Interventions
PF-08634404
BIOLOGICAL
Sigvotatug Vedotin
BIOLOGICAL
Combination Agent 1
BIOLOGICAL
Locations 32
Japan (2)
Kansai Medical University Hospital
Hirakata , Osaka
Shizuoka Cancer Center
Nagaizumi-cho , Shizuoka
Puerto Rico (2)
Pan American Center for Oncology Trials, LLC
Rio Piedras
BRCR Global Puerto Rico - Hato Rey
San Juan
Taiwan (5)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
NOT_YET_RECRUITING
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Mackay Memorial Hospital
Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
United States (23)
BRCR Medical Center Inc.
Coral Springs , Florida
Rocky Mountain Cancer Centers, LLP
Denver , Colorado
Oncology Associates of Oregon, P.C.
Eugene , Oregon
Highlands Oncology Group, PA
Fayetteville , Arkansas
Providence Medical Foundation
Fullerton , California
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
Fullerton , California
Providence St. Jude Medical Center
Fullerton , California
Dallas Cancer Specialists
Garland , Texas
NOT_YET_RECRUITING
Southwest Oncology Associates
Houston , Texas
NOT_YET_RECRUITING
Lumi Research
Houston , Texas
NOT_YET_RECRUITING
US Oncology Investigational Products Center (IPC)
Irving , Texas
Mid Florida Hematology and Oncology Center
Orange City , Florida
VCU Medical Center Gateway Building
Richmond , Virginia
Virginia Commonwealth University
Richmond , Virginia
VCU Health Stony Point
Richmond , Virginia
Massey Cancer Center Clinical & Translational Research Lab
Richmond , Virginia
Virginia Commonwealth University
Richmond , Virginia
Highlands Oncology Group, PA
Rogers , Arkansas
VCU Health Community Memorial Hospital
South Hill , Virginia
Highlands Oncology Group, PA
Springdale , Arkansas
Voyage Clinical
Sugar Land , Texas
NOT_YET_RECRUITING
BRCR Global - Tamarac
Tamarac , Florida
VCU Health Tappahannock Hospital
Tappahannock , Virginia
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.01.2026
Completion date
23.08.2033
Registry ID
NCT07227298
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.