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

NCT07227298 · Pfizer
In plain English

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Official title
AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 162 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-30
Estimated completion: 2033-08-23
Last updated: 2026-06-04
Interventions
Biological: PF-08634404Biological: Sigvotatug VedotinBiological: Combination Agent 1
Primary outcomes
  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Through 90 days after the last study intervention; Up to approximately 5 years)
  • Phase I: Number of participants with dose limiting toxicity (DLT) (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 (Up to approximately 5 Years)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (45)
Highlands Oncology Group, PARecruiting
Fayetteville, Arkansas, United States
Highlands Oncology Group, PARecruiting
Rogers, Arkansas, United States
Highlands Oncology Group, PARecruiting
Springdale, Arkansas, United States
Providence Medical FoundationRecruiting
Fullerton, California, United States
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion CenterRecruiting
Fullerton, California, United States
Providence St. Jude Medical CenterRecruiting
Fullerton, California, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Denver, Colorado, United States
BRCR Medical Center Inc.Recruiting
Coral Springs, Florida, United States
Mid Florida Hematology and Oncology CenterRecruiting
Orange City, Florida, United States
Orlando Health Ambulatory Care CenterRecruiting
Orlando, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Orlando Health Orlando Regional Medical CenterRecruiting
Orlando, Florida, United States
BRCR Global - TamaracRecruiting
Tamarac, Florida, United States
Montefiore Medical Center- Montefiore Medical ParkRecruiting
The Bronx, New York, United States
Oncology Associates of Oregon, P.C.Recruiting
Eugene, Oregon, United States
Dallas Cancer SpecialistsRecruiting
Garland, Texas, United States
Southwest Oncology AssociatesRecruiting
Houston, Texas, United States
Lumi ResearchRecruiting
Houston, Texas, United States
US Oncology Investigational Products Center (IPC)Recruiting
Irving, Texas, United States
Voyage ClinicalRecruiting
Sugar Land, Texas, United States
VCU Medical Center Gateway BuildingRecruiting
Richmond, Virginia, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
VCU Health Stony PointRecruiting
Richmond, Virginia, United States
Massey Cancer Center Clinical & Translational Research LabRecruiting
Richmond, Virginia, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
VCU Health Community Memorial HospitalRecruiting
South Hill, Virginia, United States
VCU Health Tappahannock HospitalRecruiting
Tappahannock, Virginia, United States
Beijing Cancer hospitalNot Yet Recruiting
Beijing, Beijing Municipality, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyNot Yet Recruiting
Wuhan, Hubei, China
Taizhou Hospital of Zhejiang ProvinceNot Yet Recruiting
Taizhou, Zhejiang, China
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)Not Yet Recruiting
Fano, Pesaro AND Urbino, Italy
IRCCS Istituto Nazionale dei Tumori Regina ElenaNot Yet Recruiting
Roma, ROME, Italy
Ospedale Isola Tiberina - Gemelli IsolaNot Yet Recruiting
Roma, ROME, Italy
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
Shizuoka Cancer CenterRecruiting
Nagaizumi-cho, Shizuoka, Japan
Pan American Center for Oncology Trials, LLCRecruiting
Rio Piedras, Puerto Rico
BRCR Global Puerto Rico - Hato ReyRecruiting
San Juan, Puerto Rico
Hospital de la Santa Creu i Sant PauNot Yet Recruiting
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario San CecilioNot Yet Recruiting
Granada, Spain
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital at KaohsiungRecruiting
Kaohsiung City, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Mackay Memorial HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers · TrialPath