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NCT07318805PHASE1Recruiting

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Pfizer

Start Date

12/23/2025

Completion Date

4/14/2030

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * Active malignancy within 3 years prior to enrollment * Known symptomatic brain metastases requiring steroids * Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term * Prior irradiation to \>25% of the bone marrow * Hypertension that cannot be controlled by optimal medical therapy * Renal impairment * Hepatic dysfunction * Cardiac abnormalities * Active bleeding disorder * Active or history of clinically significant GI disease * Other unacceptable abnormalities as defined by protocol

Interventions

DRUG

PF-08032562

DRUG

Fulvestrant

DRUG

Cetuximab

DRUG

Fluorouracil

DRUG

Oxaliplatin

DRUG

Leucovorin

DRUG

Bevacizumab

Interested in This Trial?

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Conditions

Advanced Breast CancerMetastatic Breast Cancer (HR+/ HER2-)Colorectal CancerMetastatic Colorectal AdenocarcinomaTriple Negative Breast Cancer

Locations

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

Duarte, California 91010

United States

START Midwest, LLC

Grand Rapids, Michigan 49546

United States

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York 11101

United States

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center 53rd street.

New York, New York 10022

United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York 10065

United States

The University of Texas MD Anderson Cancer Center - Conroe

Conroe, Texas 77384

United States

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

Houston, Texas 77030

United States

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

Houston, Texas 77079

United States

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

League City, Texas 77573

United States

START San Antonio

San Antonio, Texas 78229

United States

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

Sugar Land, Texas 77478

United States

START Mountain Region

West Valley City, Utah 84119

United States