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
Summary
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.
Arms & interventions
- BiologicalPF-08634404
-Concentrate for solution for infusion
- BiologicalSigvotatug Vedotin
-Powder for concentrate for solution for infusion. Single use vial
- BiologicalCombination Agent 1
-Powder for concentrate for solution for infusion. Single use vial.
Outcome measures
Primary
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Through 90 days after the last study intervention; Up to approximately 5 years
Phase I: Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Time frame: 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
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.
Time frame: Up to approximately 5 Years
Secondary
Phase I: Confirmed ORR per RECIST v1.1 by investigator
Time frame: Up to approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1 by investigator
Time frame: Up to approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator
Time frame: Up to approximately 5 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Time frame: Up to approximately 5 years
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Through 90 days after the last study intervention; Up to approximately 5 years
Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents
Time frame: Up to 37 days after the last dose of treatment
Eligibility criteria
Study locations (27)
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Providence Medical Foundation
Fullerton, California, 92835
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California, 92835
Providence St. Jude Medical Center
Fullerton, California, 92835
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
BRCR Medical Center Inc.
Coral Springs, Florida, 33065
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806
Orlando Health Cancer Institute
Orlando, Florida, 32806
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
BRCR Global - Tamarac
Tamarac, Florida, 33321
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, 10461
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Dallas Cancer Specialists
Garland, Texas, 75042
Southwest Oncology Associates
Houston, Texas, 77030
Lumi Research
Houston, Texas, 77090
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
Voyage Clinical
Sugar Land, Texas, 77479
VCU Medical Center Gateway Building
Richmond, Virginia, 23219
Virginia Commonwealth University
Richmond, Virginia, 23219
VCU Health Stony Point
Richmond, Virginia, 23235
Massey Cancer Center Clinical & Translational Research Lab
Richmond, Virginia, 23298
Virginia Commonwealth University
Richmond, Virginia, 23298
VCU Health Community Memorial Hospital
South Hill, Virginia, 23970
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560