PF-08032562 for advanced breast cancer and colorectal cancer
Tests PF-08032562 alone or with other treatments in adults with advanced breast or colorectal cancer.
Plain-language title generated from the registry record
Registry title: A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Key facts
- Where
- Conroe, Duarte, Grand Rapids, Houston, League City, Long Island City, New York, San Antonio, Sugar Land, and West Valley City, United StatesSee the 13 sites
- Phase
- Phase 1
Where in United States
- The University of Texas MD Anderson Cancer Center - ConroeConroe, United StatesTaking people
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesTaking people
- START Midwest, LLCGrand Rapids, United StatesTaking people
- The University of Texas M. D. Anderson Cancer CenterHouston, United StatesTaking people
- The University of Texas, MD Anderson Cancer Center - West HoustonHouston, United StatesTaking people
- The University of Texas, MD Anderson Cancer Center - League CityLeague City, United StatesTaking people
- Memorial Sloan Kettering Cancer Center - Investigational Drug Service PharmacyLong Island City, United StatesTaking people
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesTaking people
- Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesTaking people
- Memorial Sloan Kettering Cancer Center 53rd street.New York, United StatesTaking people
- START | San AntonioSan Antonio, United StatesTaking people
- The University of Texas, MD Anderson Cancer Center - Sugar LandSugar Land, United StatesTaking people
- START Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT07318805EU 2025-524387-38-00
- Record updated
- 5 November 2026
- Original description
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.Read full original descriptionShow less
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.
This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).
All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.
Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.
Inclusion: 18 years of age or older; Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease; Measurable disease; ECOG performance status 0 or 1.
Exclusion: Active malignancy within 3 years prior to enrollment; Known symptomatic brain metastases requiring steroids; Prior irradiation to >25% of the bone marrow; Hypertension that cannot be controlled by optimal medical therapy; Renal impairment; Cardiac abnormalities; Active bleeding disorder; Active or history of clinically significant GI disease; Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term; Hepatic dysfunction; Other unacceptable abnormalities as defined by protocol.