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A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2). In part 1, we are seeking participants who: * Have been diagnosed with Breast Cancer (BC) of either types: * Have HR+, HER2- BC * Refractory HR-positive/HER2-positive BC * Have other solid tumors other than BC In part 2, we are seeking participants who: -Have HR-positive/HER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091. In part 2, participants will take 1 of 2 study medicine combinations. This will help us decide the highest amount of study medicines that can be safety given to people. All participants in this study will receive PF-07220060 with PF-07104091 by mouth. We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective. Participants will take part in this study for about 2 years. During this time, they will receive the study medicine, an x-ray imaging, and will be observed for safety and effects of the study medicines.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UCLA Hematology / Oncology-Parkside
Santa Monica, California, United States
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Start Date
March 14, 2022
Primary Completion Date
August 23, 2026
Completion Date
August 23, 2026
Last Updated
November 18, 2024
192
ACTUAL participants
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07104091 + PF-07220060 + fulvestrant dose expansion
DRUG
PF-07104091 + PF-07220060 + fulvestrant dose expansion
DRUG
PF-07104091 + PF-07220060 + letrozole dose expansion
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
PF-07220060 + PF-07104091 combination dose escalation
DRUG
Lead Sponsor
Pfizer
NCT05372640
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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