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A Study of PF-08032562 for Advanced or Metastatic Solid Tumors

This study is looking into a medicine called PF-08032562 for people with advanced or metastatic (spread to other parts of the body) breast cancer or colorectal cancer. The goal is to learn how safe PF-08032562 is and how well it works, both on its own and when given with other cancer treatments like Fulvestrant, Cetuximab, or a combination of Fluorouracil and Oxaliplatin (FOLFOX). Researchers also want to find the best dose of PF-08032562. You would take PF-08032562 by mouth in 28-day cycles. The study is currently enrolling participants aged 18 and older.

Study design
This interventional study plans to enroll 260 participants. It is designed to learn about the safety and effects of PF-08032562 alone or with other anti-cancer therapies.
What's involved
You would take the study medication PF-08032562 by mouth in 28-day cycles. Depending on the study part, you may also receive other anti-cancer medications.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to 30 days after your last dose of study treatment or until a new anti-cancer therapy begins, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07318805

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~260 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-08032562FulvestrantCetuximabFluorouracilOxaliplatinLeucovorin

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)
Measured over Baseline up to 28 days
+3 more outcomes measured

Conditions

Advanced Breast Cancer
Metastatic Breast Cancer (HR+/ HER2-)
Colorectal Cancer
Metastatic Colorectal Adenocarcinoma
Triple Negative Breast Cancer

Explore related trials

Breast CarcinomaColorectal CarcinomaSolid Neoplasm

Where it's being run

13 sites across 5 states
Texas6
New York4
California1
Michigan1
Utah1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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
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

What this trial measures

  • Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)Baseline up to 28 days

    Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.

  • Part 1 (Dose Escalation): Number of participants with laboratory abnormalitiesFrom start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

    Number of participants with laboratory test abnormalities.

  • Part 1 (Dose Escalation): Incidence of Adverse Events (AEs)From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

    An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

  • Part 2 (Dose Expansion): Objective Response Rate (ORR)Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

    ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).