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New pill shows promise in early trial for Hard-to-Treat cancers

NCT ID NCT07318805

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This early-stage study is testing a new oral drug, PF-08032562, in people with advanced breast or colorectal cancer that has spread. The drug is given alone or with other cancer treatments. The main goals are to check safety, find the right dose, and see if it shrinks tumors. About 260 participants are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-08032562 (a pill taken by mouth)
What this could lead to
If successful, this could lead to a new treatment option for advanced breast and colorectal cancers that have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial, so safety and dosing are still being determined. The drug may not work or could cause side effects. It is not yet proven to be effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm colonic neoplasm colorectal adenocarcinoma colorectal cancer colorectal neoplasm hormone receptor-positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Colorectal cancer Metastatic breast cancer (HR+/ HER2-) Metastatic colorectal adenocarcinoma Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Duarte, California, 91010, United States

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

    RECRUITING

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    RECRUITING

    Long Island City, New York, 11101, United States

  • Memorial Sloan Kettering Cancer Center - Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center 53rd street.

    RECRUITING

    New York, New York, 10022, United States

  • START Midwest, LLC

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Texas MD Anderson Cancer Center - Conroe

    RECRUITING

    Conroe, Texas, 77384, United States

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

    RECRUITING

    League City, Texas, 77573, United States

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

    RECRUITING

    Sugar Land, Texas, 77478, United States

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

    RECRUITING

    Houston, Texas, 77079, United States

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