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New drug combo shows promise for Hard-to-Treat cancers

NCT ID NCT04557449

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a new drug called PF-07220060 in people with advanced solid tumors, including breast, prostate, lung, and liposarcoma cancers. The drug is given alone or with hormone therapies to see if it is safe and works. About 362 participants will take part to find the best dose and check for side effects.

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

362 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Nov 2027

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 * Part 1: Breast Cancer (BC) * Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC * Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC * Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests * Part 1F: prostate cancer * Part 2A, 2B, 2C and 2E: * HR-positive/HER2-negative BC * Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only) * Part 1D: metastatic castration resistant prostate cancer * Lesion: * Part 1: evaluable lesion (including skin or bone lesion only) * Part 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1 * Part 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded. * Prior systemic Treatment * Part 1: HR-positive/HER2-negative BC * At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator * At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease * HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy * Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available * Part 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed * Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC * Part 2C: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or * Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal * One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy * Part 2D: * Received prior abiraterone; enzalutamide and CDK4i naive * 0-1 line of chemotherapy is allowed General Inclusion Criteria * All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Adequate renal, liver, and bone marrow function Exclusion Criteria: * Part 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal * Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor * Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway * Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 4 weeks prior to study intervention * Last anti-cancer treatment within 2 weeks prior to study intervention * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Pregnant or breastfeeding female participant * Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung breast neoplasm castration-resistant prostate carcinoma colorectal cancer colorectal neoplasm hormone receptor-positive breast cancer liposarcoma lung adenocarcinoma metastatic prostate carcinoma non-small cell lung carcinoma prostate cancer triple-positive breast carcinoma

As listed by the trial registrant

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

Adenocarcinoma of lung Breast neoplasms Liposarcoma Prostate cancer

Contacts and locations

Locations

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.

    Mexico City, Mexico City, 04700, Mexico

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021, China

  • Cancer Research UK Edinburgh Centre

    Edinburgh, Edinburgh, CITY of, EH4 2XR, United Kingdom

  • Clínica Universitaria Reina Fabiola

    Córdoba, X50004FHP, Argentina

  • Dana Farber Cancer Institute- Chestnut Hill

    Newton, Massachusetts, 02467, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Ellison Institute

    Los Angeles, California, 90064, United States

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nové Zámky, 940 34, Slovakia

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE, Argentina

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, Ciudad Autã³noma de Buenos Aires, 1125, Argentina

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hospital Británico de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

  • Hospital MAC Periferico Sur

    Mexico City, Mexico City, 04700, Mexico

  • Hospital Reforma

    Oaxaca City, Oaxaca, 68000, Mexico

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460, Mexico

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • INCAN

    Mexico City, Mexico City, 14080, Mexico

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Oaxaca Site Management Organization

    Oaxaca City, 68000, Mexico

  • Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA

    Bratislava, 812 50, Slovakia

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • Smilow Cancer Hospital - Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital - Yale New Haven Health

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511, United States

  • St Bartholomew's Hospital

    London, London, CITY of, EC1A 7BE, United Kingdom

  • The Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061, China

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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

    Houston, Texas, 77079, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP

    New Haven, Connecticut, 06511, United States

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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