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New pfizer drug takes on Hard-to-Treat cancers

NCT ID NCT04606446

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called PF-07248144, alone or combined with other cancer treatments, in people with advanced breast, prostate, or lung cancers that have not responded to standard therapy. The trial aims to find safe doses and check for early signs of tumor shrinkage. About 320 participants will take part across multiple locations.

What this could mean

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

Active substance
PF-07248144 (a KAT6 inhibitor drug)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced breast, prostate, or lung cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2a) focused mainly on safety and dosing, so it is not yet known if the drug will effectively shrink tumors or improve survival. Side effects are still being identified.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

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

Started

Nov 2020

Expected to finish

Aug 2029

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: * Disease Characteristics - Breast, Prostate, and Lung Cancer * Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available. * Part 1B, Part 1C, Part 1D and Part 1E (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting. * Part 2A (ER+HER2- breast cancer 2L+, monotherapy) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4/6 inhibitor and 1 line of endocrine therapy. * Part 2B (ER+HER2- breast cancer 2-4L, combination with fulvestrant) Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy.. Participants must not have received more than 3 prior lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant. * Part 2D (ER+HER2- breast cancer 2-4L, combination with PF-07220060 (CDK4i) and fulvestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy. * Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant. * Part 2E (ER+HER2- breast cancer 2-4L, combination with vepdegestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy; Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have received fulvestrant * Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards. * Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH/DISH) defined as a HER2/CEP17 ratio \<2 or for single probe assessment a HER2 copy number \<4. * Female participants with ER+HER2- advanced or metastatic breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause. * Female participants with ER+HER2- advanced or metastatic breast cancer of nonchildbearing potential must meet at least 1 criteria of achieving postmenopausal status. * Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated. * Eastern Cooperative Oncology Group (ECOG) Performance Status PS 0 or 1 * Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years). * Adequate renal, liver, and bone marrow function. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for adverse events (AEs) not constituting a safety risk by investigator judgment. Exclusion Criteria: * Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor). * Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * Major surgery, radiation therapy, or systemic anti-cancer therapy within 3 weeks prior to study entry. * Prior irradiation to \>25% of the bone marrow. * ECG clinically relevant abnormalities (eg, QTc \>470 msec, complete LBBB, second/third degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia). * Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor. * Known or suspected hypersensitivity or severe allergy to active ingredient/excipients of PF-07248144. * Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of PF-07248144 tablets. Gastroesophageal reflux disease under treatment is allowed. * Pregnant or breastfeeding female participants.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma estrogen-receptor positive breast cancer non-small cell lung carcinoma

As listed by the trial registrant

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

Locally advanced or metastatic castration-resistant prostate cancer Locally advanced or metastatic ER+ HER2- breast cancer Locally advanced or metastatic non-small cell lung cancer

How to take part

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

  1. The places running it

    41 sites in 5 countries. 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

  • Aichi Cancer Center Hospital

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Cancer Research South Australia

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cedars-Sinai Cancer at Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Chris O'Brien Lifehouse

    TERMINATED

    Camperdown, New South Wales, 2050, Australia

  • Holy Cross Hospital

    TERMINATED

    Fort Lauderdale, Florida, 33308, United States

  • HonorHealth

    TERMINATED

    Scottsdale, Arizona, 85258, United States

  • Jilin Province Tumor Hospital

    RECRUITING

    Changchun, Jilin, 130000, China

  • Jilin Province Tumor Hospital

    RECRUITING

    Changchun, Jilin, 132000, China

  • Kanagawa cancer center

    RECRUITING

    Yokohama, Kanagawa, 2418515, Japan

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, Taegu-kwangyǒkshi, 41404, South Korea

  • MD Anderson

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • MD Anderson League City

    RECRUITING

    League City, Texas, 77573, United States

  • MD Anderson The Woodlands

    RECRUITING

    Conroe, Texas, 77384, United States

  • MD Anderson West Houston

    RECRUITING

    Houston, Texas, 77079, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • SUN Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

  • Smilow Cancer Hospital Phase 1 Unit

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Smilow Cancer Hospital at Yale - New Haven

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • St. Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • St. John of God Subiaco Hospital

    RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

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

    RECRUITING

    Houston, Texas, 77030, United States

  • U.T. MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCSF Medical Center at Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

  • University Medical Center, lnc.:DBA University of Louisville Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • UofL Health Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Western Health-Sunshine & Footscray Hospitals

    RECRUITING

    St Albans, Victoria, 3021, Australia

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Yale-New Haven Hospital- Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.