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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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Hospital Universitario HM Sanchinarro
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceNot yet recruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
Villejuif CedexFranceNot yet recruiting
The University of Texas MD Anderson Cancer Center - Conroe
Coordinator of this site? Confirm its status
ConroeUnited StatesRecruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
START Midwest, LLC
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
The University of Texas M. D. Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
The University of Texas, MD Anderson Cancer Center - West Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
The University of Texas, MD Anderson Cancer Center - League City
Coordinator of this site? Confirm its status
League CityUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Coordinator of this site? Confirm its status
Long Island CityUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center 53rd street.
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Main Campus
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
START | San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
The University of Texas, MD Anderson Cancer Center - Sugar Land
Coordinator of this site? Confirm its status
Sugar LandUnited StatesRecruiting
START Mountain Region
Coordinator of this site? Confirm its status
West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.