A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
NCT05262400 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2024-11-18
Summary
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.
Conditions
Interventions
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
- DRUG
-
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
- DRUG
-
PF-07104091 + PF-07220060 + letrozole dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
- DRUG
-
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-14
- Primary Completion
- 2026-08-23
- Completion
- 2026-08-23
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Bulgaria
- China
- Czechia
- Mexico
- South Africa
- Spain
Study Locations
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