RecruitingPhase 1NCT07318805

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


Sponsor

Pfizer

Enrollment

260 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called PF-08032562 in people with advanced or metastatic breast cancer or colorectal cancer to find the right dose and assess safety. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic breast cancer or colorectal cancer - Depending on the study group: your cancer may need to have progressed after specific prior treatments (including CDK4/6 inhibitors for breast cancer, or chemotherapy/targeted therapy for colorectal cancer) - You have measurable disease on imaging - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have had another active cancer within the past 3 years - You have symptomatic brain metastases requiring steroids - Your cancer has spread to vital organs in a way that poses an immediate life threat - You have uncontrolled high blood pressure or significant kidney problems - You have received prior radiation to more than 25% of your bone marrow Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPF-08032562

Taken by mouth (PO)

DRUGFulvestrant

Selective Estrogen Receptor Degrader (SERD)

DRUGCetuximab

Monoclonal antibody (EGFR inhibitor)

DRUGFluorouracil

Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

DRUGOxaliplatin

Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)

DRUGLeucovorin

Part of FOLFOX chemotherapy regimen (folic acid analog)

DRUGBevacizumab

Monoclonal antibody (VEG-F inhibitor)


Locations(9)

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

START Midwest, LLC

Grand Rapids, Michigan, United States

The University of Texas MD Anderson Cancer Center - Conroe

Conroe, Texas, United States

The University of Texas - M.D. Anderson Cancer Center

Houston, Texas, United States

The University of Texas, MD Anderson Cancer Center - West Houston

Houston, Texas, United States

The University of Texas, MD Anderson Cancer Center - League City

League City, Texas, United States

START San Antonio

San Antonio, Texas, United States

The University of Texas, MD Anderson Cancer Center - Sugar Land

Sugar Land, Texas, United States

START Mountain Region

West Valley City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07318805


Related Trials