NCT07318805RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 23 Dec 2025
- Primary completion date
- 14 Apr 2029
- Lead sponsor
- Pfizer
- NCT number
- NCT07318805
- EU CT number
- 2025-524387-38-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 260
- From 23 Dec 2025 to the primary completion date, 14 Apr 2029
- 19 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active malignancy within 3 years prior to enrollment
- Known symptomatic brain metastases requiring steroids
- Prior irradiation to \>25% of the bone marrow
Other illness
- Hypertension that cannot be controlled by optimal medical therapy
- Renal impairment
- Cardiac abnormalities
- Active bleeding disorder
- Active or history of clinically significant GI disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif Cedex | France | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center - Conroe Coordinator of this site? Confirm its status | Conroe | United States | Recruiting |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| START Midwest, LLC Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| The University of Texas, MD Anderson Cancer Center - West Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| The University of Texas, MD Anderson Cancer Center - League City Coordinator of this site? Confirm its status | League City | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy Coordinator of this site? Confirm its status | Long Island City | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center 53rd street. Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Main Campus Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| The University of Texas, MD Anderson Cancer Center - Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.